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Garcia, J.M., Friend, J., & Allen, S. (2012). Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: A multicenter, randomized, double-blind, crossover, pilot study. Supportive Care in Cancer, 21, 129–137.

Study Purpose

To evaluate the effects of anamorelin in patients with cancer-related cachexia

Intervention Characteristics/Basic Study Process

Patients received anamorelin 50 mg/day or placebo for a three-day treatment period. This was followed by a seven-day washout period. After the washout, patients were switched to the opposite intervention. Assessments were done at baseline and at the end of each study period. Patients were stratified according to level of weight loss prior to random assignment to the treatment condition sequence.

Sample Characteristics

  • The study reported on 16 patients.
  • Mean patient age was 62 years.
  • The sample was 75% male and 25% female.
  • Patients had various tumor types.
  • Most patients had an Eastern Cooperative Oncology Group performance status of 1.
  • All patients had experienced at least a 5% weight loss in the past six months.

Setting

  • Multisite
  • Inpatient setting 
  • United States

Phase of Care and Clinical Applications

  • Patients were undergoing palliative care.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study was a double-blind, placebo-controlled, crossover, randomized controlled trial.

Measurement Instruments/Methods

  • Body weight
  • Appetite scored on a 100 mm visual analog scale
  • Anderson Symptom Assessment Scale (ASAS)
  • Edmonton Symptom Assessment Scale
  • Functional Assessment of Chronic Illness Therapy–Fatigue Scale (FACIT-F)
  • Bristol-Myers Anorexia/Cachexia Recovery Instrument
  • Caloric intake

Results

There was no treatment effect on caloric intake. Growth hormone levels were significantly greater when patients received anamorelin compared to placebo (p = 0.005). ASAS total scores improved after three days of anamorelin (p < 0.002). Among individual symptom items, patients reported improved appetite (2.67 points with anamorelin and 0.5 points with placebo, p = 0.011). FACIT-F scores improved after anamorelin  compared to placebo (p = 0.018).

Conclusions

Anamorelin was shown to have some positive effects on patients’ symptoms in this small pilot study. Further research is needed to evaluate efficacy.

Limitations

The study had a small sample size, with less than 30 participants.

Nursing Implications

This study was too small to enable any conclusions about the efficacy and safety of anamorelin. Further research with a larger sample is needed.

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Garcia Gomez, J., Perez Lopez, M. E., Garcia Mata, J., Isla Casado, D., & SEOM (Spanish Society for Medical Oncology). (2010). SEOM clinical guidelines for the treatment of antiemetic prophylaxis in cancer patients receiving chemotherapy. Clinical & Translational Oncology, 12, 770-774.

Purpose & Patient Population

To update the 2005 Spanish Society of Medical Oncology (SEOM) clinical guidelines for the treatment of chemotherapy-induced emesis and to continue to improve the supportive care of patients with cancer

Type of Resource/Evidence-Based Process

The Clinical Guideline Working Group, on behalf of the Spanish Society of Medical Oncology (SEOM) Executive Committee, provided expert opinion based on a review of the literature covering patients with cancer receiving chemotherapy.

Phase of Care and Clinical Applications

All patients were in active treatment. This paper has application to antiemetic drugs.

Guidelines & Recommendations

  • For highly emetogenic chemotherapy, one-day regimen, the following is recommended.
    • Day 1:  5-HT3 receptor antagonist (preferably palonosetron); 125 mg oral aprepitant; and 12 mg IV or oral dexamethasone
    • Days 2-3: 80 mg oral aprepitant per day
    • Days 2-4: 4 mg oral dexamethasone every 12 hours
  • For moderately emetogenic chemotherapy, one-day regimen, the following is recommended.
    • Day 1:  5-HT3 receptor antagonist and 8 mg IV or oral dexamethasone
    • Days 2-3: 4 mg oral dexamethasone every 12 hours
  • For low-emetogenic chemotherapy, the recommendation is day 1, 12 mg IV or oral dexamethasone or, alternatively, 0.5 mg/kg IV or oral metochlopromide.
  • For minimally emetogenic chemotherapy, no prophylactic antiemetics are recommended.
  • For multiple-day chemotherapy, the recommendation is day 1, 5-HT3 receptor antagonist (palonosetron) and dexamethasone.
  • For delayed emesis, dexamethasone is recommended.
  • For refractory emesis and rescue treatment, metoclopromide, benzodiazepines, and/or phenothiazines, butyrophenones, or olanzapine are recommended.
  • For acute and delayed emesis, three recommendations are made.
    • Palonosetron, a second-generation serotonin receptor antagonist, has been shown to be at least equally effective as first-generation antagonists when controlling acute emesis and more effective than first-generation antagonists when controlling delayed emesis.
    • Aprepitant, a neurokinin 1 receptor antagonist, with serotonin receptor antagonists and steroids are recommended.
    • Combining dexamethasone with other antiemetics is more effective at controlling chemotherapy-induced nausea and vomiting (CINV) than using dexamethasone alone. 
  • For anticipatory nausea and emesis, use benzodiazepines, such as lorazepam.
  • The authors cautioned that the use of metoclopramide as an antiemetic is limited by the presence of serious side effects such as akathisia, extrapyramidal reactions, and dose dependency.
     

Nursing Implications

Prevention of CINV can be accomplished through pharmacologic interventions, increasing patients' quality of life. The use of 5-HT3, along with dexamethasone and aprepitant, seems to be the most effective regimen. Although these recommendations are helpful, no insight into cost implications and little discussion of potential side effects of antiemetic treatment were provided. Additionally, the recommendations offered are purely pharmacologic and, thus, only aimed at those with prescriptive authority.

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Garcia Gomez, J., Perez Lopez, M.E., Alonso Bermejo, M., Escobar Alvarez, Y., & Garcia Mata, J. (2013). SEOM guide to antiemetic prophylaxis in cancer patients treated with chemotherapy 2013. Clinical & Translational Oncology, 15, 1030–1036. 

Purpose & Patient Population

PURPOSE: No purpose statement was identified. 
 
TYPES OF PATIENTS ADDRESSED: Patients receiving high, moderate, minimal, and refractory emetogenic chemotherapy experiencing early, late, and refractory nausea and vomiting. Preventative measures are also discussed. 

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline  
 
PROCESS OF DEVELOPMENT: The process of forming this guide was not described. The definition of nausea is also limited.
 
DATABASES USED: Not reported
 
KEYWORDS: Not reported
 
INCLUSION CRITERIA: Not reported
 
EXCLUSION CRITERIA: Not reported

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference

The authors provide tables summarizing the emetogenic potential of common chemotherapy agents, the National Cancer Institute's classification of emesis by intensity and severity, and an algorithm of chemotherapy-induced nausea and vomiting (CINV) prophylaxis. Recommended schedules for the administration of palonosetron and dexamethasone are also provided.

Guidelines & Recommendations

No succinct list of recommendations was provided by the authors. The definition of nausea is also inconsistent with the National Comprehensive Cancer Network's definition. The article describes the different types of CINV, describes the emetogenic potential of agents, and supports an algorithm to select appropriate interventions. The authors do not state their intention outright; however, this document appears to present treatment guidelines for the Spanish Society of Medical Oncology. This guide is written in a clear style and offers straightforward recommendations for the prevention and treatment of CINV. The recommendations are grounded in the evidence, although no explanation of how the evidence was retrieved is provided. It is not possible to tell if research is drawn from a suitable representation of sources to be deemed comprehensive. Forty-three references were cited ranging from 1993 to 2013. It is assumed that the recommendations are applicable towards adults and not pediatrics but this was not stated. Recommendations for refractory and salvage antiemetic therapy are provided, but it is unclear how consensus was reached for these recommendations.

Limitations

  • Limitations were not explicated by the authors.
  • Explanation of article retrieval is not provided.
  • Procedure for reaching recommendation is not provided.
  • To what degree was a consensus reached and how members resolved issues when consensus could not be reached are examples of this report’s limitations.

Nursing Implications

CINV continues to be a serious and debilitating side effect of chemotherapy for patients with cancer. Nurses should be well informed of current recommendations and guidelines for the use of 5HT3s in the prevention and treatment of CINV.

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Garavito, A.A., Cardona, A.F., Reveiz, L., Ospina, E., Yepes, A., & Ospina, V. (2008). Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: A clinical trial. Palliative & Supportive Care, 6, 371–376.

Study Purpose

To evaluate the use of colchicine solution in the treatment of mucositis in patients with hematologic malignancies undergoing chemotherapy

Intervention Characteristics/Basic Study Process

Group A (control) used a 9% sodium chloride (NaCl) and water solution. Group B used a colchicine solution of 2 mg dissolved in 500 cc of sterile water starting the first day of symptoms of oral mucositis until the fifth day of the disease (inflammatory phase). Following the fifth day, patients in group B received same as group A. The solution for both groups was prepared fresh every morning. Both groups gargled for two minutes, four times a day while being supervised by a researcher. Twice a day, patients brushed with a soft toothbrush, if possible. During the study, patients were allowed concomitant interventions for oral mucositis (OM), such as systemic antibiotics, antimycotics, antivirials, antiemetics, analgesics, and granulocyte colony-stimulating factor (G-CSF) support. Cryotherapy and other oral mouthwashes were not permitted.

Sample Characteristics

  • The study reported on 82 patients, with a median age of 42 years in group A and 50 years in group B.
  • The sample had 37 females and 45 males.
  • Patients had OM and had been diagnosed with lymphoma or acute leukemia treated with high-risk chemotherapy.

Setting

The study was conducted in an inpatient cancer center in Bogota, Columbia.

Study Design

This study used a single arm, nonrandomized, sequentially enrolled, historical control group.

Measurement Instruments/Methods

  • Oral assessments were done once a day until resolution using the World Health Organization (WHO) Oral Toxicity Scale.
  • Oral pain was evaluated twice a day using a visual analog scale (VAS).
  • Tolerability of mouthwash was evaluated by the patient once daily using a VAS.
  • Maximum daily body temperature was recorded until OM was resolved.
  • The characteristics, severity, and duration of OM, length of inpatient hospitalization, severity of OM-related pain, days of opioid consumption, tolerability of mouthwashes, change in oral pH (using pH meter), and occurrence of infection were evaluated using the Mann-Whitney test and Fisher’s exact test.
  • Statistical analyses were performed using the SPSS 12.0 Statistical package.

Results

  • Patients in the treatment group experienced significantly lower median duration of OM (6 days versus 9 days) (p = 0.028).
  • Patients in the treatment group experienced significantly fewer median days to healing of mucosal lesions (4 days versus 7 days) (p = 0.047).
  • No differences were found in the number of days of hospitalizations, variations in weight, voice characteristics, salivation production, mucosal pH, and frequency and volume of oral mucosal bleeding.
  • Oral pain assessment was similar, and no significant differences were found in opioid consumption.
  • No differences were found in tolerability of mouthwashes.
  • No serious side effects were reported with colchicine mouthwash.
  • No differences were found in incidence of febrile neutropenia.

Conclusions

Colchicine mouthwash may be helpful in reducing the severity and duration of chemotherapy-induced OM.

Limitations

  • The sample size was small.
  • The study was not randomized or blinded.
  • Patients were able to use multiple other interventions for mucositis. Use of these interventions was not reported or discussed, so one cannot tell which interventions actually had an effect.

Nursing Implications

Further studies are needed to confirm results. This was done in an inpatient setting under direct supervision; these findings may not be applicable in other situations.

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Garassino, M.C., Piva, S., La Verde, N., Spagnoletti, I., Iorno, V., Carbone, C., . . . Farina, G. (2013). Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PloS One, 8(4), e59981.

Study Purpose

To evaluate two different dose escalation approaches for the combination of oxycodone and pregabalin

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either 20 mg per day sustained-release oxycodone and escalating doses of pregabalin starting at 50 mg per day, or to pregabalin at 50 mg per day and escalating doses of oxycodone. Patients were observed for 14 days. The primary endpoint of the study was overall analgesia, defined as pain intensity reduction by at least one-third on a numeric rating scale.

Sample Characteristics

  • N = 67
  • MEAN AGE = 67.5 years
  • AGE RANGE = 39–85 years
  • MALES: 56.7%, FEMALES: 43.3%
  • KEY DISEASE CHARACTERISTICS: Lung, breast, and colon cancer were most prevalent.
  • OTHER KEY SAMPLE CHARACTERISTICS: 72% had baseline pain scores of 6 or lower.

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Outpatient 
  • LOCATION: Italy

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

  • Randomized, parallel group

Measurement Instruments/Methods

  • Pain numeric rating scale
  • Allodynia recorded as present or absent by physical exam
  • Patient diary for daily recording of pain severity, use of other medications, and episodes of breakthrough pain

Results

Analgesia as defined was achieved in the pregabalin escalation group with a mean dose of 100 mg and in the other group with a mean dose of 60 mg oxycodone. No differences were seen between groups in use of rescue medication, other analgesics, or side effects.

Conclusions

Strategies for managing neuropathic pain with either dose escalation of pregabalin or escalation of sustained-release oxycodone when given in combination produced similar results.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Other limitations/explanation: Short duration of the study

Nursing Implications

Findings suggest that similar pain management effects can be achieved with either escalation of pregabalin or escalation of oxycodone when given in combination for neuropathic pain. These findings suggest that either approach may provide similar effects and that the approach used can be determined according to relevant patient characteristics and preferences.

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Gao, H., Liang, Y., Zhou, N., Zhang, D., & Wu, H. (2011). Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin-based chemotherapy. Internal Medicine Journal, 43, 73-76.

Study Purpose

To evaluate the efficacy and safety of aprepitant in combination with palonsetron and dexamethasone in patients receiving three-day cisplatin-based chemotherapy

Intervention Characteristics/Basic Study Process

  • Patients received three-day cisplatin-based chemotherapy and had never been treated with aprepitant. 
  • All patients received the same antiemetic regimen of aprepitant 125 mg orally before chemotherapy on day 1 and 80 mg orally once daily on the following two days. 
  • Palonosetron was given on days 1 and 3, and dexamethasone was given on days 1, 2, and 3. 
  • The study physician evaluated efficacy and safety daily for seven days.  
  • Patients were evaluated over multiple cycles of chemotherapy if applicable.

Sample Characteristics

  • The study consisted of 41 patients receiving a total of 89 cycles of chemotherapy.
  • The median age of participants was 52.8 years (range = 21-74 years).
  • Twenty-four patients (59%) were male, and 17 (41%) were female.
  • Diagnoses were lung (32), nasopharyngeal (3), testicular (2), esophagus (2), stomach (1), and oropharyngeal (1).
  • Eight of the patients were chemotherapy-naïve; 27 patients had a history of smoking, 16 had a history of drinking, 11 had a history of motion sickness, and 12 had a history of morning sickness.

 

Setting

This was a single-site study conducted in Guangzhou, China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a prospective, nonrandomized study.

Measurement Instruments/Methods

Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute, version 3.0, was used to assess nausea and safety.

Results

  • Findings indicated that 17% of patients had no nausea, 54% had grade 1 nausea, and 29% had grade 2 nausea. 
  • With regard to vomiting, 63% had no vomiting in the acute phase, 78% had no vomiting in the delayed phase, and 58.5% had no vomiting overall. The number of patients reporting no vomiting decreased from 85% on day 1 of chemotherapy to 65% on day 3. 
  • The most common side effects were hiccups (37%), fatigue (17%), headache (15%), and constipation (12%).  No adverse events were grade 2 or more. No cumulative toxicities from multiple chemotherapy cycles were reported.

Conclusions

Triple antiemetic medications of aprepitant, palonosetron, and dexamethasone are safe and effective for multiple-day chemotherapy to prevent vomiting.  The antiemetic efficacy is maintained during multiple chemotherapy cycles. The regimen was not as effective in preventing nausea.

Limitations

  • This study had a small sample of fewer than 100 participants.
  • No control group was included. 
  • The study was conducted at a single institution. 
  • This was a nonrandomized study. 
  • Descriptions of how the variables were measured were poor. For example, no information was provided on how vomiting was monitored and recorded.

Nursing Implications

Using the combination of aprepitant, palonosetron, and dexamethasone is effective in decreasing the incidence of chemotherapy-induced nausea and vomiting (CINV) in multiple-day chemotherapy regimens with low incidence of toxicity. Control of the symptom of nausea remains problematic.

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Gao, L., Yang, Y.J., Xu, H.Y., Zhou, J., Hong, H., Wang, Y.L., & Li, D.C. (2014). A randomized clinical trial of nerve block to manage end-stage pancreatic cancerous pain. Tumour, 35, 2297–2301. 

Study Purpose

To determine the effectiveness of nerve blocks to control pain in patients with end-stage pancreatic cancer pain

Intervention Characteristics/Basic Study Process

Patients were randomized to two groups, the sham and nerve block groups. Visual Analog Scale (VAS) pain scores, pain duration, reduction of other analgesics, and quality of life scores (measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) were obtained before and three months after intervention.

Sample Characteristics

  • N = 100  
  • MEAN AGE = 65.5 years
  • MALES: Unknown, FEMALES: Unknown 
  • KEY DISEASE CHARACTERISTICS: Unresectable or inoperable carcinoma of the pancreas by CT or EUS; stage determined by the 2010 American Joint Committee on Cancer (AJCC) manual; presence of midabdominal pain at a minimum of two days per week for at least one hour per day; INR 1.5; platelets greater than 50,000; life expectancy greater than three months
  • OTHER KEY SAMPLE CHARACTERISTICS: Age had to be greater than 18; excluded if unable to sign consent; excluded if patient had previous blocks; excluded if patient had chronic pancreatitis

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified    
  • LOCATION: Not specified; approved by Soochow University Ethical Committee in China

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Elder care, palliative care 

Study Design

Sham-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Results

The neurolysis group (N) and sham group (S) did not demonstrate a difference in pain. At three months, group N had a significant (p < 0.05) improvement in pain. Pain duration decreased (14.6 ± 0.3 hours per day to 6.1 ± 0.2 hours per day; p < 0.05) in group N compared to group S before and after the intervention. Group S had no significant change. Reduction of other analgesic medication in groups N versus S was significant (p < 0.05), specifically for NSAIDs and oxycodone among others excluding morphine. At three months, quality of life (QL), function (physical and emotional), and symptoms scales improved in the N group versus the S group. Notably, appetite loss, symptoms scores, and insomnia improved the most.

Conclusions

This study presents a potential additional intervention in combination with pain medication in patients with end-stage pancreatic cancer-associated pain. Additional potential benefits could be the improvement of physical and emotional function, fatigue, insomnia, and loss of appetite. This study would have to be replicated with a larger sample size to prove efficacy.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: Follow-up period was limited to three months; location of tumor was not identified; prior therapies not identified; less generalizable sample size 100

Nursing Implications

This type of therapy presents a potential intervention in combination with pain medication for pain control in end-stage pancreatic cancer based on this randomized, controlled trial. After-care of a patient with a nerve block would require training. An assessment of the adjustment of other medicinal treatments would be required at baseline in this intervention.

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Ganz, P. A., Greendale, G. A., Petersen, L., Zibecchi, L., Kahn, B., & Belin, T. R. (2000). Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. Journal of the National Cancer Institute, 92, 1054-1064.

Study Purpose

This study intended to test the effectiveness of a comprehensive menopausal assessment (CMA) on symptom relief, quality of life, and sexual functioning.

Intervention Characteristics/Basic Study Process

Participants were randomized by age (≤55 and >55) and tamoxifen use (current vs. not used). The CMA was delivered by a trained nurse practitioner with a specialty in family and women’s health over a 4-month period and focused on structured symptom assessment of hot flashes, vaginal dryness, and stress urinary incontinence. After assessment, patients were provided with individualized education and counseling, psychosocial support, referrals, and individualized follow-up. Specific pharmacologic and behavioral interventions for the target symptoms were implemented to control symptoms based on treatment protocols developed by the NP and the study physician. The intervention group returned for a 2-month follow-up visit. The usual care group received a telephone call 2 months after baseline to ask about therapies used to manage their symptoms. Data was collected at baseline and 4 months. The usual care group was then able to take part in the CMA but no further data was collected.

Sample Characteristics

  • The study enrolled 42 women with breast cancer.

Setting

  • SITE:  Single site    
  • SETTING TYPE : Outpatient    
  • LOCATION: California/community recruitment

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Menopausal Symptom Scale Score (adapted from the Breast Cancer Prevention Trial Symptom Checklist)
  • Vitality Scale from the RAND 36-item Health Survey (aka Medical Outcomes Study SF-36)
  • Sexual Summary Scale from the Cancer Rehabilitation Evaluation (CARES)

Results

97% of women in the study reported hot flashes at baseline, with no difference between groups. There was a significant difference in the menopause symptom scale (p=.0004), with women in the intervention group showing the most improvement in symptoms. There was no difference between groups in QOL (p=.77). The CMA group had significantly better sexual functioning at follow-up compared to the usual care group (p=.02). No specific data on improvement in hot flashes was provided. Only the overall symptom scale was reported.

Conclusions

CMA is an effective intervention to improve/reduce the number of menopausal symptoms in breast cancer survivors and to improve sexual function for these women.

Limitations

Limitations of the study included:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Intervention expensive, impractical, or training needs
  • Requires a specially trained nurse practitioner for the intervention

Nursing Implications

A nurse-led intervention to target menopausal symptoms is an effective way to reduce these symptoms in women who are survivors of breast cancer. However, the intervention may be too expensive or impractical given the training requirements of the intervention nurse and institutional guidelines on billable appointments.

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Ganti, B.R., Marini, B.L., Nagel, J., Bixby, D., & Perissinotti, A.J. (2017). Impact of antibacterial prophylaxis during reinduction chemotherapy for relapse/refractory acute myeloid leukemia. Supportive Care in Cancer, 25, 541–547. 

Study Purpose

To evaluate the effects of prophylaxis with levofloxacin in relapsed/refractory acute myeloid leukemia (AML)

Intervention Characteristics/Basic Study Process

Data were obtained from medical records of patients with relapsed or refractory AML admitted from 2006–2015. Standard levofloxacin prophylaxis was begun in 2013 with 500 mg once daily on day 1 of chemotherapy and continued until neutrophil recovery. Cohorts who received levofloxacin were compared to a cohort that did not receive prophylaxis.

Sample Characteristics

  • N = 145   
  • MEDIAN AGE = 58–59 years
  • AGE RANGE = 18–84 years
  • MALES: 67%, FEMALES: 33%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All had relapsed AML and were undergoing re-induction chemotherapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients on broad spectrum antibiotics or who were receiving other prophylaxis were excluded. Eighteen percent had previously undergone hematopoietic cell transplantation.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Michigan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort comparison

Measurement Instruments/Methods

Febrile neutropenia (FN) was defined as an oral temperature of 38.3 C or greater with and absolute neutrophil count less than 500 cells/mm3

Results

A lower rate of bacteremia existed in the prophylaxis group, but the difference was not significant. The time to onset of bacteremia from onset of neutropenia was delayed in the prophylaxis group compared to others (p = 0.012). No differences in drug-resistant organisms existed between cohorts, or in the incidence of FN. In the prophylaxis group, the frequency of gram-negative organism–related infections was lower.

Conclusions

Levofloxacin prophylaxis reduced the number of overall infections and the prevalence of gram-negative infections in patients being treated for relapsed or refractory AML.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

The findings suggest that antibiotic prophylaxis is beneficial for patients undergoing re-induction chemotherapy for relapsed or refractory AML.

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Gandemer, V., Le Deley, M., Dollfus, C., Auvrignon, A., Bonnaure-Mallet, M., Duval, M., … Schmitt, C. (2007). Multicenter randomized trial of chewing gum for preventing oral mucositis in children receiving chemotherapy. Journal of Pediatric Hematology/Oncology, 29, 86–94.

Intervention Characteristics/Basic Study Process

Patients chewed five to six pieces of fluoride-containing, sugar-free gum, sweetened with xylitol per day for 20 minutes per piece from the first day of chemotherapy to three days after course of treatment. Both groups practiced standard oral care, consisting of brushing teeth with a soft toothbrush and rinsing with sodium bicarbonate rinse.

Sample Characteristics

  • The study reported on 145 children ages 5–18 years. The gum group had 73 patients, and the control group had 72 patients.
  • All patients were scheduled to receive chemotherapy associated with at least a 30% rate of grade 3–4 oral mucositis according to the World Health Organization (WHO) oral mucositis grading scale.

Setting

The study was conducted between March 1999 and December 2002.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

Researchers recorded the WHO grade of mucositis within first 21 days, time to development of grade 3–4 mucositis, incidence of any grade of mucositis, incidence of pain using a 70-point visual analogue scale, number of days of total parenteral nutrition, incidence of abdominal symptoms, and incidence of septicemia.

Results

No significant differences were found between arms for severe mucositis endpoints.

Patients receiving less toxic regimens had a decrease in WHO grade 1–4 oral mucositis of 49% in the gum group and 72% in the control group (p = 0.03).
 

Limitations

  • This study did not achieve adequate sample size according to power analysis.
  • Eight children discontinued using the gum because of nausea.
  • Chlorhexidine and fungizone were widely used in both arms.
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