Oral Care Protocol

Database searched was MEDLINE (1993–2003) for randomized, controlled trials evaluating mucositis interventions.

A total of 50 randomized controlled trials were presented. Other trials and papers were referenced.

• Sample sizes ranged from 10–222.
• Patients were treated with chemotherapy, radiotherapy, and bone marrow transplantation.

The author concluded that most agents require more study.

• Evidence for cryotherapy and bolus 5-fluorouracil was strong.
• Sucralfate studies produced conflicting results and included varying doses and administration frequencies, making comparisons difficult. Most studies indicated no difference in severity or duration. The validity and reliability of the data were questioned because of the measurement scales used.
• Similarly, studies of cytokine-like agents used different doses, making comparisons difficult.
• Moderate evidence suggested that benzydamine is effective in relieving mouth pain caused by radiation-induced mucositis in patients with head and neck cancer. The agent requires additional investigation and study for chemotherapy-induced mucositis.
• Large studies of chlorhexidine mouthwashes have failed to show significant findings; however, the studies may have had inadequate sample sizes, as power analyses were not performed.
• Povidone-iodine showed significant reduction in onset, incidence, total duration, and worst grade of mucositis for patients with head and neck cancer undergoing radiation with carboplatin in two studies. Both studies had sample sizes of 40. Given these sample sizes and specific populations, generalizability of the findings was restricted.
• Oral hygiene protocols were shown to reduce the duration and severity of mucositis; however, the content of the protocols was not proven.

The author noted the problem of variation in study protocols, insufficient sample sizes, and a lack of consensus regarding the scoring system for mucositis.

The author noted the need to include psychotherapeutic interventions and management and pointed out the lack of a quality-of-life tool for mucositis.

STUDY PURPOSE: To systematically review oral care interventions for the prevention and treatment of oral mucositis (OM) in patients undergoing cancer treatment

TYPE OF STUDY: Systematic review

DATABASES USED: Ovid MEDLINE

KEYWORDS: mucositis, stomatitis, cancer, oral care, oral care protocol, dental care, dental cleaning, oral decontamination, oral hygiene, saline, sodium bicarbonate, baking soda, chlorhexidine, magic/miracle mouthwash, calcium phosphate

INCLUSION CRITERIA: Primary research article, reflects a variety of research designs, rested the effects of intervention on severity of OM or mucositis-related symptoms

EXCLUSION CRITERIA: Review articles, clinical case reports, literature reviews, non-research articles

TOTAL REFERENCES RETRIEVED = 129

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Hadorn et al. criteria was used to assess the flaws in the selected publications, and levels of evidence were rated using the Somerfield schema.

FINAL NUMBER STUDIES INCLUDED = 52

SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Not stated

PHASE OF CARE: Active antitumor treatment

The guidelines are as follows.

• Oral care protocols: Oral care was suggested for the prevention of OM in adult and pediatric populations for all types of cancer therapies. No population-specific guidelines were recommended.
• Dental care (by a professional): No guidelines were recommended for dental care in the prevention of OM.
• Normal saline: No guidelines were recommended for normal saline for the prevention or treatment of OM.
• Sodium bicarbonate rinse: No guidelines were recommended for sodium bicarbonate for the prevention or treatment of OM.
• Chlorhexidine: No guidelines were recommended for chlorhexidine for the prevention or treatment of OM in patients receiving standard chemotherapy or hematopoietic stem cell transplantation. Guidelines suggest that chlorhexidine not be used to prevent OM in patients with head and neck cancer treated with radiotherapy.
• Mixed medication mouthwash: No guidelines were recommended for mixed medication mouthwash for the prevention or treatment of OM.
• Calcium phosphate: No guidelines were recommended for calcium phosphate for the prevention or treatment of OM.

Oral care protocols are recommended to patients for the prevention and treatment of OM. Chlorhexidine is not recommended for patients with head and neck cancer who receive radiotherapy treatment.

Evidence for interventions to prevent and treat OM are limited, making guideline recommendations difficult.

Nurses should teach patients appropriate oral care to help prevent OM.

To investigate, critically appraise, and rate the evidence regarding agents used for the prevention of mucositis in children

Databases searched included CINAHL, Cochrane library, Ovid MEDLINE, PubMed, BioMed Central, and other internet-based sources. A total of 19 databases were searched.

Search keywords were mucositis, stomatitis, oral inflammation, mouth mucosal inflammation, prophylaxis, management, and prevent; in addition to keywords to identify children and all types of cancer therapy.

Studies were included in the search if they

• Involved English-speaking children.
• Were clinical trials conducted on the prevention of oral mucositis during cancer therapy.

Studies were excluded if they

• Were not in English
• Did not involve children
• Involved only gastrointestinal mucositis.
• Involved treatment of mucositis rather than prevention.
• Were case studies or pilot studies.
• Were commentaries or letters to the editor.
• Involved sample sizes of less than 20 patients.

• The total number of references retrieved was 16,471.
• The authors evaluated the references using the Canadian Task Force on Preventive Health Care evidence-based guidelines.

• The final number of studies was 27. The sample range across studies was not reported.
• Other than inclusion of pediatric cases, no other characteristics were described.

• Patients were undergoing the active antitumor treatment phase of care.
• The study has clinical applicability for pediatrics.

• The studies involved the following interventions.
  • Oral care protocols (n = 5)
  • Chlorhexidine mouthwash (n = 7) 
  • Benzydamine mouthwash (n = 1)
  • Iseganan mouthwash (n = 1),
  • Granulocyte macrophage-colony stimulating factor (GM-CSF) mouthwash (n = 2)
  • Oral glutamine (n = 2)
  • Enteral glutamine (n = 1)
  • Oral propantheline and cryotherapy (n = 1)
  • Oral cryotherapy (n = 1)
  • Oral sucralfate suspension (n = 1)
  • Prostaglandin E2 tablets (n = 1)
  • Chewing gum (n = 1)
  • Laser therapy (n = 3). 
• Good evidential support was found for the use of oral care protocols. Fair support was found for the use of chlorhexidine with some mixed results.
• Only one article was found that studied benzydamine, CSF, and iseganan. The evidence was deemed insufficient to make a recommendation. 
• Good evidential support was found against the use of sucralfate and prostaglandin E2 tablets.
• Evidence regarding laser use and oral and enteral glutamine were mixed.

The authors concluded that oral care protocols should be used; oral sucralfate suspension, prostaglandin E2, and GM-CSF mouthwash should not be considered based on current evidence; and chlorhexidine (without use as part of an oral care protocol), laser therapy, and glutamine should not be considered because of conflicting evidence.

• No disease or treatment factors were reported or considered in the analysis. 
• Some interventions were evaluated in only one study.
• The quality of the evidence in general was highly variable.
• No information was provided on how the outcome for mucositis was measured in the included studies.
• The authors recommendations suggest no use of a specific intervention if findings were conflicting, which assumes that insufficient evidence of effectiveness is equivalent to ineffectiveness.

Findings provide further support for use of oral care protocols. Results provided no other useful recommendations for preventive therapies but identified the need for further research in this area.

Database searched was MEDLINE (1966–2001). Additional papers were found from reference lists.

Studies were included in the review if they were aimed at prevention, palliation, or reduction of radiation-induced oral mucositis in patients with head and neck cancer.

Studies were excluded if they were not in English.

More than 50 studies were included. Most were randomized, controlled trials; some were pilot or descriptive studies. 

Sample sizes ranged from 10 to more than 200.

Based on the findings of studies conducted to date, no conclusions regarding the agents and their ability to decrease the severity of radiation-induced oral mucositis were possible. Results were inconsistent. The most effective measure to treat radiation-induced mucositis was frequent oral rinsing with a bland mouthwash such as saline or sodium bicarbonate. Consistent oral care, dental care, oral assessment, and standardized oral hygiene were the suggested approaches to managing oral mucositis. Sodium bicarbonate reduces the acidity of the oral fluids immediately; it also dilutes accumulating mucus and discourages yeast colonization.

Findings related to benzydamine were inconsistent. In a trial of chlorhexidine versus benzydamine, patients reported more discomfort with benzydamine and were more likely to discontinue participation in the trial. Chlorhexidine was not effective in reducing the severity of mucositis in three double-blind, placebo-controlled trials. Two trials that examined antimicrobial activity failed to show any significant effects on the suppression of any type of oral flora using chlorhexidine.

Dose variations in granulocyte macrophage colony-stimulating factor (subcutaneous) trials make it impossible to determine whether this agent has a role in the radiation setting.

Four studies investigated the effectiveness of using topical antibiotics with a more specific spectrum for gram-negative bacteria and yeast. Two placebo-controlled, randomized clinical trials, both with fewer than 100 patients, and one case-controlled study investigated the efficacy of amphotericin B (polymyxis E, tobramycin, and amphotericin B [PTA] lozenge) to reduce the severity of radiation-induced mucositis. One study examined tetracaine and antibiotics. Additional work is warranted to determine the effects of the PTA lozenge on mucositis severity, pain severity, and dysphagia. Results for the trial were promising; however, conclusions cannot be drawn because only one study examined tetracaine.

Additional investigation of immunoglobulin and povidone-iodine are recommended.

To develop a mucositis oral care protocol and evaluate the impact of its implementation in the prevention and management of mucositis in the patient with hematopoietic cell transplant (HCT)

A standard protocol was developed. After development, the physician and nursing staff were educated about the protocol and effects of medications included in the protocol. Following education for three months, every patient admitted to the HCT service was managed according to the protocol. Retrospective review of the electronic medical record of mucositis management was done in cases during the three months prior to protocol use. The new protocol was included in the electronic order set used for HCT admissions.

The protocol included daily evaluation, brushing twice daily, ice chips 30 minutes prior to and throughout melphalan infusion, chlorhexidine gluconate mouthwash 15 ml 4 times daily, normal saline mouthwash 30 ml four times daily, calcium phosphate rinse 30 ml four times daily, magic mouthwash 15 ml four times daily as needed for oral pain, and phenol losenges every two hours as needed for oral pain. Palifermin was used at the physician’s discretion.

• The study reported on 24 patients receiving HCT (11 retrospective and 13 prospective).
• Mean age was 55 years (SD = 12) in the retrospective group and 59 years (SD = 12) in the prospective group.
• The sample was 76% female and 24% male.
• All were patients hospitalized for HCT. Most patients were receiving BEAM (carmustine, etoposide, cytarabine, melphalan) chemotherapy.

This was a single-site study conducted in an inpatient transplant unit at the Mayo Clinic in Florida.

The study used an exploratory descriptive design with historical controls.

• The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading system was used.
• Data was retrieved by retrospective chart review.
• Use and duration of total parenteral nutrition (TPN) was recorded, as well as hospital length of stay.

• Patients who received the oral care protocol had lower incidence of grade 1 mucositis and lower duration of grade 1 mucositis (p = 0.02).
• No differences were found at any other grade level between groups.

• The sample size was small.
• The data was from chart audit only.
• No information was provided about actual components used and protocol adherence.
• Although TPN on the grading scale is indicative of grade 3 mucositis, only 17% of patients receiving TPN with the new protocol were grade 3. This calls the validity of findings into question.

This study does not significantly add to our understanding for the management of mucositis but suggests that use of a standardized protocol increases attention to mucositis management. This study also raises questions about the use of the criteria as receiving TPN as a measure of mucositis grade, as use of TPN may not only be a result of mucositis. This area of limitation also may indicate issues of reliability in the documentation of mucositis grade, as data here were solely obtained from the electronic medical record.

The study was conducted over an eight-month period. The first four months were with the control group, which received routine care, no oral protocol, and the center's standard use of 0.9% sodium chloride (NaCl) and benzydamine hydrochloride rinse to control oral mucositis (OM) when it developed.

The last four months involved the experimental group, which received an oral care protocol consisting of patient education, maintenance of patient diaries, and rinsing with normal saline chlorhexidine every two hours on days 1–21. The oral protocol prescribed toothbrushing; NaCl solution rinse for gums, tongue, and soft tissue; and chlorhexidine rinse every morning and evening, as well as NaCl rinse after each meal and every two hours for the second week only.

• The study reported on 42 children (21 in the control group and 21 in the experimental group) with hemotological or solid malignancies.
• Mean age was 10.3 years and a range of 6–18 years.

This was a prospective, comparative study.

• Oral assessment was performed initially and two times per week in each group.
• The Eilers Oral Assessment Guide was used.
• The Faces Pain Scale was used.
• Patients were observed for fevers and neutropenia.

• The oral protocol group experienced a 38% reduction of OM.
• Severity of OM (p = 0.000002) and related pain (p = 0.0001) were significantly reduced in the intervention group.
• The mean neutrophil count varied significantly between the seven time point evaluations (p = 0.008). A moderate negative correlation was found between the presence of OM and neutrophil count of the control group (p = 0.46) and protocol group (p = 0.15). Intensity of OM pain was significantly correlated with score of OM in two groups (p = 0.007).

• Assessment was performed twice per week.
• The results may not be generalizable to adult patients.
• The sample size was smal.
• A variety of chemotherapy protocols were used.
• The experimental group may have experienced a study effect.
• Use of chlorhexidine recommendation is in conflict with Multinational Association of Supportive Care in Cancer (MASCC) recommendations.

Although the sample is small, the evidence supports the use of normal saline found in other studies.

Test the effectiveness of three mouthwashes used to treat chemo-induced OM. Compared: salt/soda, (1 t each/pint of water) chlorhexidine and magic mouthwash (lidocaine, benadryl Maalox).
 

Also used the Pro-Self program for all patients. Nurses presented the Pro-Self Mouth Aware program to patients and provided them with mouthwash. This program incorporates good oral hygiene, new toothbrush, daily flossing, regular oral assessments, and instruction of oral conditions that the patient must bring attention to the nurse.

Oral assessment and oral protocol 4x/day. Swished MW for 20 sec and then discard. The MW bottles were collected after their sx subsided or after 12 days supply. Measured amount remaining in bottles.
 

The mean age was 59.05 years.  
Chemo- not RT to head and neck or leukemia
 

23 outpatient/office settings, 202 patients (142 final pts)

Randomized, double-blind trial to 1 of 3 mouthwashes.

• Oral assessment done when patient entered study. Oral assessment guide was taught to all patients by nurses.
• Patient reports QOD via phone to nurse.
• Use chi-square test, one-way analysis of variance
   

Forty-seven patients dropped out, 11 took > 12 days to report a cessation of s/s.
No significance in three groups of demographics, disease-related variables. No significant difference in the time to reported cessation of the signs and symptoms from chemo-induced mucositis among the three groups (p = 0.59).
The average pain scores did not differ significantly (p = 0.79).
 

Patient reports, no clinician assessment during mucositis

Limitation of OAG tool – this guide addresses information of oral cavity changes and not strictly mucositis

Structure of oral care program may have been the greatest effect on mucositis.
 

Findings support use of NS/baking soda over chlorhexidine and magic mouthwash – especially with established oral care program.

To assess the impact of saline mouth rinse regimen and education program on radiation-induced OM symptoms and QOL in patients with oral cavity cancer receiving RT or CCRT.

Ninety‐one OCC patients were randomly divided into a group that received saline mouth rinses and an education program and a control group that received standard care. OM symptoms and QOL were assessed with the WHO Oral Toxicity Scale, MSS‐moo, and UW‐QOL. Data were collected at the first postoperative visit to the radiation department (T0) and at 4 weeks and 8 weeks after beginning RT or CCRT.

• N: 91   
• AGE: 20 years or older
• MALES: 93.8%  
• FEMALES: 6.2%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy  
• KEY DISEASE CHARACTERISTICS: Diagnosed with oral cavity cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Undergoing postoperative adjuvant RT or CCRT

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Cancer center in northern Taiwan

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care

Double-blind RCT one control and two intervention groups.

OM symptoms and QOL were assessed with the WHO Oral Toxicity Scale, MSS‐moo, and UW‐QOL. Data were collected at the first postoperative visit to the radiation department (T0) and at 4 weeks and 8 weeks after beginning RT or CCRT.

Patients in both groups had significantly higher levels of physical and social‐emotional QOL at 8 weeks after beginning RT or CCRT compared to the first visit. Patients in the saline rinse group had significantly better physical and social‐emotional QOL as compared to the standard care group at 8 weeks. Radiation‐induced OM symptoms and overall QOL were not different between the groups.

The authors concluded that the saline rinse and education program promote better physical and social‐emotional QOL in OCC patients receiving RT/CCRT. The results of this study indicated that saline mouth rinses with an education program were effective in increasing physical and social‐emotional QOL by improving the radiation‐induced OM symptoms and promoting oral comfort in patients receiving RT/CCRT for HNC, as compared to standard care. However, no improvement in radiation‐induced OM symptoms and overall QOL was found.

• Small sample (< 100)
• Other limitations/explanation: Small study with limitations in descriptive measurement.

It might be helpful to provide and teach saline mouth rinses to patients

To determine the effect of an oral mucositis prevention protocol on nutritional status and quality of life in patients receiving radiation therapy for head and neck cancers

The intervention group received an oral care protocol that included tooth brushing, features of the tooth brush, and a sodium bicarbonate mouth rinse. It also included an oral evaluation, precautions for oral mucositis, and a nutrition protocol. The nutrition protocol consisted of recommendations for wounds, irritation, intensive secretion, xerostomia, smell or taste changes, nausea, vomiting, and nutritional principles after radiation therapy (RT). The protocols were used for preventing oral mucositis and malnutrition, and interventions were used according to the grading of mucositis. Assessments were done weekly for seven weeks.

• N = 50  
• AGE = less than 39 to greater than 60
• MALES: 86%, FEMALES: 14%
• KEY DISEASE CHARACTERISTICS: Nasopharyngeal, laryngeal, salivary gland, gingiva, hypo pharyngeal, and tongue
• OTHER KEY SAMPLE CHARACTERISTICS: Education status from illiterate to high school or higher

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care and palliative care 

Randomized, controlled, experimental study

• Face to face interviews were done using an oral assessment guide, oral toxicity scale from the World Health Organization (WHO), a Visual Analog Scale (VAS), the Subjective Global Assessment (SGA) index, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).
• A data analysis was conducted using SPSS v15.0 and SigmaStat v3.5.

Oral mucositis severity was lower in the group receiving the oral care protocol compared to the control group. As the post-treatment period progressed, the prevalence of malnutrition in the intervention group was lower than the control group, and the intervention group experienced significantly less pain related to oral mucositis. A similar deterioration in quality of life was noted in each group.

Oral mucositis severity was lower in the two groups receiving the oral care protocol compared to the control group. This study demonstrated that oral mucositis rate may be reduced with an oral care protocol.

• Small sample (< 100)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: This study reported a number of patients who experienced occasional breakdowns in RT treatment devices with delays that could have affected results. It was not clear what care patients in the control group received when they developed mucositis.

Nurses working in RT units should explain oral care protocols to patients before treatment and assess patients' mouths every week using evidence-based assessment criteria. Healthcare professionals should evaluate the nutritional status of individuals receiving RT before, during, and after treatment, and patients should be offered education and training. Nurses should use evidence-based protocols for patient care. This study added to the body of evidence pointing to the importance and effectiveness of standardized oral care for the reduction of mucositis severity.

To compare the incidence of oral mucositis (OM) in patients conditioned with myloablative conditioning (MAC) versus reduced-intensity conditioning (RIC) and to determine the effect of a new oral care protocol

A radiographic full-mouth exam and an oral exam by an investigating dentist were performed one week prior to hematopoietic stem cell transplantation (HSCT). Prior to the start of conditioning, daily oral exams began three days prior to HSCT for 25 days or until discharge. A dentist or dental hygienist assessed oral cavities three times per week. From 2007 to 2010, 142 patients used a protocol (soft tooth brushing twice daily only; no interdental brushes, toothpicks, or flossing were allowed). From 2010 to 2011, 29 patients received the intensive protocol (intensive protocol brushing, interdental brushes or flossing, sucking on ice chips every two to three hours while awake, rinsing normal saline solution every two hours while awake from transplantation until neutrophil count was > 0.5). Dental infections foci were treated conservatively.

• N = 171
• MEDIAN AGE = 50 years
• MALES: 53.2%, FEMALES: 46.7%
• KEY DISEASE CHARACTERISTICS: Allogeneic HSCT; 94% malignant disease; 5% nonmalignant; 12% previous HSCT; 44% early-stage; 56% late-stage
• OTHER KEY SAMPLE CHARACTERISTICS: 57 human leukocyte antigen identical sibling or related donors; 101 unrelated donors; 13 antigen-mismatched, unrelated donors

• SITE: Single-site
• SETTING TYPE: Inpatient
• LOCATION: Karolinska University Hospital in Huddinge, Sweden

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

Quasi-experimental

• World Health Organization (WHO)
• Visual Analog Scale (VAS) for pain
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v3)
• Oral function (ability to swallow)
• Subjective opinion of function of saliva

Patients treated with the oral protocol in 2011 had significantly lower OM scores than those treated with the previous protocol (p = 0.013).

MAC conditioning was correlated with significantly higher OM scores (p < 0.001). Lower OM scores were associated with the intensive oral protocol intervention. Patients treated in later years (2011) demonstrated a decrease in OM scores, which were caused by an increased use of RIC and improved standards of oral care.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The actual sample size for the oral care intervention was only 29 participants. In addition, the authors began the article comparing different conditioning regimens then added in the oral care intervention.

Oral mucositis is a side effect of the conditioning regimens for HSCT. This study revealed that with consistent assessment, support, and a more intensive oral care protocol using ice and normal saline rinses, there is a potential to reduce the severity of this side effect. More nursing research is needed in this area.

To determine the effectiveness of an oral management program in reducing oral mucositis (OM) incidence and severity in patients undergoing stem cell transplant (SCT)

Patients undergoing hematopoietic SCT were retrospectively enrolled in a study to determine if the occurrence and severity of OM was significantly different between a group of patients who received appropriate oral management and those who did not. The control group underwent SCT in 2007–2008, and the oral management group in 2009. This study included an oral evaluation, from the same oral health professionals, for all 48 enrollees prior to SCT. All serious dental issues (e.g., periodontitis, tooth extraction) were treated prior to starting SCT. Patients in the oral management group received oral care instruction with the transplant team prior to SCT. They also received an additional oral exam from the dentist and hygienist as well as instructions (including tooth brushing and oral swab use), based on their OM status. Both groups were treated with the same medications, based on the same OM toxicity scale, as graded by trained SCT nurses. OM in both groups was treated with azulene sodium sulfate and 4% lidocaine rinse.

• The study reported on 48 patients with cancer.
• The age range of the sample was 16–66 years.
• The sample was 48% male and 52% female.
• Cancer diagnoses included malignant lymphoma, acute myelogenous leukemia, acute lymphocytic leukemia, myleodysplastic syndrome, and multiple myeloma.
• Most of the patients had received allogeneic transplant (n = 35). 
• Significantly more patients in the OM group received allogeneic HCT.
• Ifosfamide, carboplatin, and etoposide (ICE) and fludarabine + melphalan/total body irradiation (TBI) conditioning regimens were significantly different between the oral management and control groups.  

This was a single-site inpatient study conducted at the Tsukuba University Hospital in Tsukuba, Japan.

Patients were undergoing the active antitumor treatment phase of care.

This was an observational, two-group trial.

OM was graded using the National Cancer Institute's (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE, version 3.0).

• The incidence of any grade OM was significantly lower in the oral management group (p < 0.05).
• The median of the most severe OM score was 2 for the control group and 1 for the oral management group. This difference was statistically significant (p < 0.05).
• No significant difference was found between the groups in the duration of oral pain; however, the oral management group showed a tendency toward a shorter duration of pain (p < 0.1).
• All patients with sepsis, in both groups, recovered with antibiotics. No significant difference was found in the incidence of sepsis or in the amount of pain medication required.

Oral management was associated with lower incidence of OM and lower average severity of mucositis in patients undergoing HCT.

• The sample size was small with fewer than 100 patients.
• Important differences existed at baseline between groups, including the prevalence of allogeneic HCT. Key differences could have influenced results.
• A risk of bias exists because of the lack of a control group, blinding, and random assigment, as well as the sample characteristics.
• The study is further limited by the specific treatment group tested and the fact that it was a retroactive study .
• The investigators did not describe specific ongoing oral self care and if this differed between groups. Additionally, patient adherence to daily oral care was not evaluated.

With this study’s evidence, nurses can educate patients and reinforce continued oral care at home as well as recommend dental evaluation prior to starting chemotherapy for patients with oral health issues. These measures should help to reduce oral side effects and reassure patients that they have some control over disease management.

To investigate the effects of providing mouth care education to pediatric patients with cancer on their degree of mucositis

This study was designed to provide mouth care education using written and visual material. Participants were placed in the control group (prior to the start of chemotherapy and and the education intervention) and the research group after intervention. Patients and their mothers were taught an oral care protocol including brushing teeth and gargling with salt water glutamine mouth wash twice daily, then brushing teeth an additional two times per day.

• N = 16    
• AVERAGE AGE = 13.9 years (range = 8–18 years)
• MALES: 31%, FEMALES: 69%
• KEY DISEASE CHARACTERISTICS: Overall, 56% of patients were diagnosed with leukemia or lymphoma, 62.5% were at an advanced stage and in a high-risk group, and 44% were receiving chemotherapy for six days or more.
• OTHER KEY SAMPLE CHARACTERISTICS: In total, 68.75% of participants reported that they received mouth care education from healthcare providers, 75% reported that they received education related to oral mucositis, and 93.75% were irregularly practicing mouth care.

• SITE: Single site
• SETTING TYPE: Inpatient hematology/oncology pediatric clinic    
• LOCATION: A university hospital in Turkey

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

This was a quasi-experimental longitudinal study designed to examine the influence of planned mouth care education on oral mucositis severity and associated pain.

• The data collection tools used were the Child and Parent Information Form (CPIF), World Health Organization (WHO) Oral Mucositis Index (OMI), and the Children’s International Mucositis Evaluation Scale (ChIMES) developed specifically to evaluate mucositis-related symptoms in pediatric patients with cancer.

The difference between the median oral mucositis severity before and after the education intervention was statistically significant according to the OMI (p < 0.05). Actual differences varied across study days. Children indicated that they practiced oral care irregularly. There was a statistically significant difference between the children’s pain scores before and after the program.

Planned mouth care education using written and visual material specifically designed for pediatric patients with cancer beginning on the very first day of diagnosis was helpful as an intervention for pain and mucositis. It also promoted the routine monitoring of each patient’s mouth care practices and assessments of oral mucositis and pain severity using valid and reliable scales at each visit.

• Small sample (< 30)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Findings not generalizable
• Other limitations/explanation: This study was conducted at one medical center, and there was a time limitation because it was a part of a graduate dissertation project. It was unclear if the information provided regarding the children’s adherence to oral care was gathered from baseline assessments or after the education program. The findings of this study were most applicable to a third-world population with minimal oral hygiene habits.

Nurses have an essential role in providing education and monitoring oral mucositis protocols that can be implemented as part of routine care in a hospital inpatient or infusion clinic setting. The results of this study were favorable in part because of the routine follow-up visits that ensured the effectiveness of the education program. Routine visits were established at the initial visit and included education reinforcement, the promotion of oral care practices, physical assessments, and evaluations of associated pain. These can be supported as interventions for PEP^® pain management. Participants in this study were from a population in which there was little regular oral care as part of regular hygiene habits.

To observe the benefits of implementing an oral care protocol in the identification and treatment of stomatitis in patients with head and neck cancer receiving radiation and chemotherapy

Databases searched were CINAHL, the Cochrane Central Register of Controlled Trials, and Medline.

Search keywords were stomatitis, mucositis, mucous membrane, treatment protocols, clinical practice guidelines, radiation therapy, and chemotherapy.

A protocol was developed based on the literature. Nursing education was conducted regarding grading stomatitis based on World Health Organizaiton (WHO) guidelines and interventions for each grade. Patient education was developed regarding the key components of oral hygiene, along with creation of a stomatitis brochure. Chart audits were evaluated for a 20-day period pre- and post-intervention.

After protocol implementation, more cases of stomatitis were identified and stomatitis was identified at an earlier stage of severity.

Protocol use gives nurses the tools to identify high-risk patients and provide treatment.

Daily oral assessment and protocol use reduces the severity of stomatitis resulting in improved patient outcomes. This project could have been expanded and carried one step further by looking at both patients' and nurses' satisfaction and perceived effectiveness of the program.

• RESOURCE TYPE: Evidence-based guideline

• PHASE OF CARE: Active antitumor treatment

No information is provided regarding the volume of evidence retrieved or quality ratings of studies included.

• Oral hygiene
• Pretreatment control of preexisting periodontal and dental disease with professional cleaning
• Routine use of palifermin is not recommended.

• Regular oral care with use of nonalcohol-containing mouthwashes
• At least weekly assessment

All specific interventions had either recommendations against use or no ability to provide a recommendation. Cryotherapy even with bolus 5-FU was not recommended due to lack of evidence in the setting of RT for patients with head and neck cancer. The guideline provides a listing of numerous interventions that have been examined with no recommendations for use.

• Limited search and no clear study quality rating
• Unclear if the panel reviewed all the evidence or just statements created by an individual facilitator

This review provides a comprehensive list of interventions, none of which can be recommended for practice. This article does provide a good overview of assessment instruments and provides some information on probable risk factors.

PURPOSE: To review effective strategies to assist nurses in caring for patients receiving sorafenib, with the focus on those adverse effects the group felt were most difficult to manage—hand-foot syndrome, diarrhea, fatigue, and oral complications

TYPES OF PATIENTS ADDRESSED: Patients receiving sorafenib for renal cell or hepatocellular cancer

RESOURCE TYPE: Evidence-based guideline

DATABASES USED: PubMed, Cochrane Library, and hand-searching of the Clinical Journal of Oncology Nursing and American Society of Clinical Oncology website     

KEYWORDS: Side effect general terms, and specific terms for each side effect (e.g., altered taste, hand-foot syndrome); disease-related search terms included renal cancer, cancer of the kidneys, hepatocellular carcinoma, and liver cancer

INCLUSION CRITERIA: Evidence base included wider literature regarding the management of similar adverse events in patients with other types of cancer and other types of antitumor therapy. No other specific criteria were stated.

EXCLUSION CRITERIA: Not stated
 

• PHASE OF CARE: Active antitumor treatment            
• APPLICATIONS: Late effects and survivorship

Out of 2,469 initial citations retrieved, 37 were included for review. No specific quality evaluation of citations was done due to the nature of the literature, with few clinical trials. No description of the group process used is provided. Findings from citations reviewed were outlined and a review of the literature was provided, but no actual synthesis of evidence exists. Noted is that most evidence in this area is from experience.

Recommendations for mucositis include oral care, amifostine, and antibiotic paste for prophylaxis. For symptom management, recommendations include ice chips, topical lidocaine solutions, sage tea and baking soda oral rinses, and topical solution containing aloe vera, and advising patient to avoid tobacco, alcohol, and spicy foods, mucosal coating agents (e.g., Gelclair®), hydrolytic enzymes, and treatment interruption. For diarrhea, recommendations are patient education, loperamide, diphenoxylate, cholestyramine, probiotics, tincture of opium, and antidiarrheal agents, and avoidance of lactose, high roughage, fatty and spicy foods, fruit juice, and caffeine. For hand-foot syndrome, recommendations include use of emollients, wearing gloves, and avoiding constrictive footwear, hot water, urea- or salicylate-containing creams, and treatment interruptions. For fatigue, recommendations include encouraging activity, maintaining normal work and social schedules, providing supportive care, and considering antidepressants, methylphenidate, sleep medication, and treatment-free intervals.

This review adds nothing new to the limited body of evidence in this area, and does not include a huge body of literature related to the management of fatigue and diarrhea symptoms. Most evidence reviewed was of low quality and expert opinion. No process by which the group evaluated the evidence strength in order to make full recommendations is described, and the result is generally a listing of previously documented opinions related to the management of these symptoms.

This review provides recommended assessments and management approaches that are at the level of expert opinion only.

To review current knowledge and provide guidance to clinicians regarding care for the prevention of mucositis, particularly pediatric patients

The databases searched and search keywords were not stated.

This study has clinical applicability to pediatrics.

Experts generally agree that oral care is important and that oral care instructions should include brushing teeth 2–3 times per day, flossing, rinsing with a bland agent such as sterile water, using fluoride therapy, and using mouth moisturizers. These measures are recommended regardless of hematologic status. Experts recommend changing toothbrushes frequently. Dental assessments should be performed at initial diagnosis. This report provides a summary of the oral care guidelines of four organizations.

This report provides general recommendations for oral hygiene but no specific review of evidence or evidence quality.

This report provides a general overview and supports the development and implementation of specific protocols based on evidence for oral care.

570 articles were included in this literature review. Literature contained prevention and/or treatment methods for mucositis. Interventions for treatment of mucositis were given, recommendations against an intervention were provided, suggestions in favor of an intervention were supplied, and suggestions against an intervention were given.

Recommendations included a combination of teeth brushing, flossing, mouth rinsing, and use of growth factors and cytokines in treatment of mucositis. The use of anti-inflammatory agents was also recommended. Low level laser therapy was recommended in prevention of mucositis with specific types of cancer treatment. Cryotherapy was also recommended for patients receiving chemotherapy. A list of natural and miscellaneous agents was recommended for treatment and prevention of mucositis.

Limitations of this study include clinical situations that were not seen in the literature review or that are rare in clinical settings. These limitations occur because of conflicting evidence or not enough evidence provided.

Nurses should be assessing patients' pain control, nutritional support, ability to eat, and oral hygiene practices, and should be teaching on the use of oral care products that are essential for prevention.

RESOURCE TYPE: Evidence-based guideline

• Not reported

• Basic oral care will reduce severity of oral mucositis and associated pain.
• An opioid-based systemic pain control program is usually needed.
• Topical coating agents and anesthetics may reduce mucosal sensitivity, but with short duration.
• Topical capsaicin should not be used.
• A transmucosal opioid is a rational approach to odynophagia, which should be viewed as incidental breakthrough pain.

No quality rating of evidence used is discussed, and numerous consensus statements are not supported by evidence or any references.

This guideline is a mix of consensus-based and evidence-based recommendations. Nurses should be aware of the need for patients to continue trying to swallow to avoid disuse muscle atrophy and fibrosis from treatment. This guideline suggests that pain on swallowing be managed as breakthrough pain, and that transmucosal opioids would be an appropriate approach for management.

To summarize the evidence around the use of radiotherapy, standard-dose chemotherapy, and high-dose chemotherapy with or without total body irradiation plus hematopoietic stem cell transplantation (HSCT) for the management of mucositis

• Databases searched were the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO).
• Evidence was evaluated based on the American Society of Clinical Oncology (ASCO) Levels of Evidence (I-V) and Grades of Recommendation (A-D). Statements without grading were considered justified standard clinical practice by the expert authors and the European Society for Medical Oncology (ESMO) faculty.

• Institutions should develop oral care protocols based on clinical practice and interdisciplinary involvement. Staff and patient education are essential. Basic oral care should include saline mouth rinses 4–6 times per day and use of a soft toothbrush replaced on a regular basis. 
• Patient-controlled analgesic (PCA) with morphine is recommended for the treatment of pain in patients with oral mucositis undergoing HSCT.
• Regular oral pain assessment and topical anesthetics can provide short-term pain relief. 
• Chlorhexidine rinses are not recommended to treat established mucositis but may be an option to enhance treatment of oral infection.
• Benzydamine oral rinse is recommended for prevention of mucositis in patients with head and neck cancer receiving radiotherapy.
• For prevention of mucositis in patients receiving standard-dose chemotherapy,
  • Oral cryotherapy for 30 minutes is recommended in patients receiving fluorouracil (5-FU).
  • Keratinocyte growth factor-1 (palifermin) 40 mcg/kg per day for three days may be useful in patients receiving bolus 5-FU plus leucovorin.
• For prevention of mucositis in patients receiving high-dose chemotherapy with or without total body irradiation plus HSCT, the following are recommended.
  • Palifermin 60 mcg/kg per day for three days prior to transplant and three days post-transplant
  • Cryotherapy in high-dose melphalan
  • Low-level laser therapy (LLLT) before HSCT

The primary author was the principal investigator on the National Institutes of Health (NIH) R13 Conference Grant that provided partial support for the symposium “Oral Complications of Emerging Cancer Therapies,” 14-15 April 2009, Bethesda, MD, USA. Production of a Journal of the National Cancer Institute (JNCI) Monograph for conference publications was supported by an unrestricted educational grant form Biovirum, which owned palifermin at the time of the publication. Peterson also is a member of the Scientific Advisory Board and a paid consultant for the GI Co., Inc, which is responsible for the development of recombinant intestinal trefoil factor, for which the phase II study is cited in the references.

The mucositis guidelines reported contain few changes from the previous two versions of the ESMO Clinical Practice Guidelines. With the 2009 MASCC/ISCO Mucositis Study Group in June 2009, it was decided that no new guidelines were warranted based on the current published literature. Progress has been made in the understanding of molecular basis of mucositis. Evidence-based, cancer-specific identification of risk factors and management of mucositis depend on clinical research so that approval of new drugs and devices will be possible.

RESOURCE TYPE: Consensus-based guideline

PROCESS OF DEVELOPMENT: Asian expert panel of head and neck cancer specialists

PHASE OF CARE: Active treatment

• Multinational Association of Supportive Care in Cancer (MASCC) guidelines
• World Health Organization (WHO) and Common Terminology Criteria for Adverse Events (CTCAE) for toxicity grading of oral mucositis
• Annals of Oncology
• The Bonner trial (Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomized trial, and relation between cetuximab-induced rash and survival. Published in Lancet Oncology in 2010)

This review and expert opinion were limited to patients with head and neck squamous cell carcinoma undergoing radiation therapy with or without cetuximab or chemotherapy. The authors’ proposal of a new grading system was noted to be adapted from the authors who previously addressed the need for a new grading system.