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Cryoanalgesia

Cryoanalgesia involves the application of a cryoprobe to nerves (Ba et al., 2015; Evans, Lloyd, & Green, 1981). The cryoprobe has a bulb at its top that cools to temperatures of -50 to -80 degrees (Ba et al., 2015; Moorjani et al., 2001). It has been studied in post-surgery pain in patients with cancer. 

Acupuncture and Methylcobalamin

Acupuncture is a method of producing analgesia or altering the function of a body system by inserting fine, wire-thin needles (about the diameter of a strand of hair) into acupoints along a specific meridian (meridians are channels in the body that transport energy) on the body. The needles are twirled or energized electronically or are warmed and left in place for approximately 20-30 minutes. Acupuncture has been evaluated in anxiety, CINV, dyspnea, pain, hot flashes, depression, lymphedema, sleep-wake disturbance, peripheral neuropathy, and fatigue.

Symptom Monitoring

Symptom monitoring refers to employing a focused and systematic approach to symptom monitoring in order to improve patient-reported outcomes.

Minocycline

Minocycline is a drug that has been traditionally used as an antibiotic and anti-inflammatory. It has been studied in animal models for the prevention of paclitaxel-induced neurotoxicity with some positive results; trials in humans are now underway. Until more results are known, minocycline for peripheral neuropathy should only be used in the context of a clinical trial. 

Dexamethasone Mouthwash

Dexamethasone is a corticosteroid. Steroid-containing oral pastes or rinses have been used to treat aphthous ulcers (Divers & O'Shaughnessy, 2015; Nicolatou-Galitis et al., 2013; Pilotte et al., 2011; Rugo et al., 2017), also known as canker sores (Mayo Clinic, 2018), and are being studied in the treatment of cancer treatment-related mucositis.

Rambod, M., Pasyar, N., & Ramzi, M. (2018). The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. European Journal of Oncology Nursing, 33, 14–21.

Study Purpose

The purpose of the study was to evaluate the effect of zinc sulfate on the incidence and severity of mucositis in patients with leukemia undergoing chemotherapy.

Intervention Characteristics/Basic Study Process

This is a randomized, placebo-controlled, triple-blinded study conducted on patients with leukemia undergoing chemotherapy. The subjects were randomized into an experimental arm where they received zinc sulfate (50 mg) three times daily for 14 days from the first day of chemotherapy; the control group received placebo capsules three times per day. Mucositis was measured by the Oral Mucositis Index and World Health Organization mucositis scale on the 4th, 7th, and 14th day after chemotherapy.

Sample Characteristics

  • N = 69   
  • MEAN AGE: 36.725 years
  • MALES: 57%  
  • FEMALES: 43%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: AML, ALL, CML

Setting

SITE: Multi-site   
SETTING TYPE: Not specified    
LOCATION: Nemaze Hospitals affiliated to SUMS, Shiraz, Iran

Phase of Care and Clinical Applications

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

Study Design

This is a randomized clinical trial and placebo-controlled study for patients undergoing chemotherapy for leukemia. Patients were randomly assigned to receive either zinc sulfate or placebo.

Measurement Instruments/Methods

  • IBM SPSS Statistics, version 20
  • Kolmogorov-Smirnov test 
  • Independent t test and chi-square test
  • Repeated measures analysis of variance (RM-ANOVA)

Results

There is significant difference in the incidence of mucositis during the 14 days of the study, 9 patients (25%) in the experimental group (zinc sulfate) and 19 (54%) in the control group (placebo) showed incidence of mucositis was 2.1 times higher in the control group. Onset of mucositis occurred on days 5.83 (SD = 3.37) (zinc sulfate) and 4.58 (SD = 2.47) (placebo), t test showed no difference between these two groups regarding the onset of mucositis (t = 0.95, p = 34). There is no confirmation of mucositis occurring later in the zinc sulfate group in comparison to the control group. The severity of mucositis was milder in the experimental group compared to the control group on 4th, 7th, and 14th day. RM-ANOVA indicated significant difference between mean score objective evaluation of mucositis the two groups (F = 7.83, p = 0.07). Results also showed significant difference between the two groups' mean score of subjective evaluation of mucositis (F = 5.79, p = 0.01)

Conclusions

The results of the study show that zinc sulfate is helpful in preventing mucositis in patients with leukemia undergoing chemotherapy. The current study does not support any significant difference between the two group in delaying onset of mucositis. The severity of mucositis was milder in the zinc sulfate group in comparison to the control group.

Limitations

  • Small sample (< 100)
  • Risk of bias (sample characteristics)
  • Findings not generalizable
  • Other limitations/explanation: Length of the study, evaluation of mucositis for a longer time

Nursing Implications

Using zinc sulfate at the dose of 50 mg three times per day for 14 days helped to prevent and decrease the severity of mucositis in the leukemia population undergoing chemotherapy. This along with standard of care oral hygiene could be an effective treatment to prevent and decrease the severity of mucositis. Additional research is needed.

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Jiang, C., Wang, H., Xia, C., Dong, Q., Chen, E., Qiu, Y., . . . Chen, T. (2018). A randomized, double-blind, placebo-controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma. Cancer, 125, 1081-1090.

Study Purpose

The purpose was to evaluate a probiotic combination on the severity of oral mucositis in patients with nasopharyngeal cancer who are undergoing concurrent chemotherapy and radiation therapy.

Intervention Characteristics/Basic Study Process

Probiotic combination (Bifidobacterium longum, Lactobacillus lactis, and Enterococcus faecium) three capsules BID from the beginning of treatment to end of treatment, up to 7 weeks.

Sample Characteristics

  • N = 99 (2:1 randomization, n = 64 in probiotic group and n = 35 in placebo group)   
  • MEAN AGE: 50.4  years in treatment group and 51.69 years in placebo group
  • MALES: N = 58 (n = 21 [60%] in treatment group, n = 37 (64%] in control group)  
  • FEMALES: N = 35 (n = 14 [40%] in treatment group, n = 21 [36%] in control group)
  • CURRENT TREATMENT: Combination radiation therapy and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: n/a

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

RCT, double-blind, placebo controlled

Measurement Instruments/Methods

Mucositis was measured with the CTCAE, version 4.0, by two senior radiation oncologists daily. Routine blood analysis, biochemical analysis, and lymphocyte immunity were measured before and after treatment.

Results

Patients in the intervention group showed a significant reduction in the severity of OM. The incidences of grade 0, 1, 2, and 3 OM in the placebo group and the probiotic combination group were 0% and 12%, 0% and 55%, 54% and 17%, and 46% and 16%, respectively. Additional genomic and biochemical analysis results reported.

Conclusions

The probiotic combination significantly reduced oral mucositis. Blood test results found that this reduction may be due to improvements in immunity. The optimal dose and schedule still needs to be explored.

Nursing Implications

Probiotics have the potential to improve outcomes related to oral mucositis in patients receiving combination chemotherapy and radiotherapy for nasopharyngeal cancer. Additional research is needed to identify the ideal dose and schedule for this treatment.

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Riley, P., Glenny, A.M., Worthington, H.V., Littlewood, A., Fernandez Mauleffinch, L.M., Clarkson, J.E., & McCabe, M.G. (2017). Interventions for preventing oral mucositis in patients with cancer receiving treatment: cytokines and growth factors. Cochrane Database of Systematic Reviews, 11, CD011990.

Purpose

  • STUDY PURPOSE: To assess the effects of cytokines and growth factors for preventing oral mucositis in patients with cancer who are receiving treatment.
  • TYPE OF STUDY: Systematic review

Search Strategy

  • DATABASES USED: Cochrane Oral Health’s information specialist searched the following databases: Cochrane Oral Health’s Trials Register (searched May 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched May 2017); MEDLINE Ovid (1946 to May 2017); Embase Ovid (December 2015 to May 2017); CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to May 2017); and CANCERLIT PubMed (1950 to May 2017). The U.S. National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. 
  • YEARS INCLUDED: Through May 2017 
  • INCLUSION CRITERIA: RCTs
  • EXCLUSION CRITERIA:Not a RCT or unclear; stomatitis incidence reported in adverse events table; unclear if mucositis was oral or gastrointestinal; study stopped early with very few participants enrolled; oral mucositis not mentioned and unknown if measured; some participants had oral mucositis at baseline; crossover study with no reporting of first-period data; results reported by cycle assuming independence; survival/cure was primary outcome with mucositis (unclear if oral or gastrointestinal) as a toxicity

Literature Evaluated

  • TOTAL REFERENCES RETRIEVED: 3,145
  • EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two review authors independently screened the results of electronic searches, extracted data, and assessed risk of bias. For dichotomous outcomes, they reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, they reported mean differences (MD) and 95% CIs. They pooled similar studies in random-effects meta-analyses. 

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED: 35 (published from 1993 to 2017) 
  • TOTAL PATIENTS INCLUDED IN REVIEW: 3,102 
  • SAMPLE RANGE ACROSS STUDIES: Fourteen studies enrolled participants with hematological cancers. Eighteen studies enrolled participants with solid cancers: head and neck, colorectal, breast, and sarcoma. The remaining three studies enrolled a mixture of participants with solid cancers and participants with hematological cancers, two of which were 80%-90% solid, and the other study only 3% solid.
  • KEY SAMPLE CHARACTERISTICS: All patients being treated for cancer, aged 1 to 87 years old

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

  • There might be a reduction in the risk of moderate to severe oral mucositis in adults receiving bone marrow/stem cell transplantation after conditioning therapy for hematological cancers (RR = 0.89, 95% CI [0.8, 0.99]; 6 studies; 852 participants; low-quality evidence).
  • A possible reduction in the risk of severe oral mucositis in bone marrow/stem cell transplantation after conditioning therapy for hematological cancers, but there is also some possibility of an increase in risk (RR = 0.85, 95% CI [0.65, 1.11]; 6 studies; 852 participants; low-quality evidence).  
  • Probably a reduction in the risk of moderate to severe oral mucositis in adults receiving radiotherapy to the head and neck with cisplatin or fluorouracil (RR = 0.91, 95% CI [0.83, 1]; 3 studies; 471 participants; moderate-quality evidence). 
  • Likely that there is a reduction in the risk of severe oral mucositis in adults receiving radiotherapy to the head and neck (RR = 0.79, 95% CI [0.69, 0.9]; 3 studies; 471 participants; high-quality evidence)
  • Likely that there is a reduction in the risk of moderate to severe oral mucositis in adults receiving chemotherapy alone for mixed solid and hematologic cancers (RR = 0.56, 95% CI [0.45, 0.7]; 4 studies; 344 participants; moderate-quality evidence)
  • Might be a reduction in the risk of severe oral mucositis in this population (RR = 0.3, 95% CI [0.14, 0.65]; 3 studies; 263 participants; low-quality evidence)

Conclusions

Although authors concluded that KGF is beneficial in the prevention of oral mucositis in adults who are receiving (a) radiotherapy to the head and neck with cisplatin or fluorouracil, or (b) chemotherapy alone for mixed solid and hematologic cancers, the results are not conclusive. Could conclude likely effective but not established

Limitations

  • Low sample sizes
  • 13 studies (37%) were at low overall risk of bias
  • 12 studies (34%) were at unclear overall risk of bias.
  • 10 studies (29%) were at high overall risk of bias

Nursing Implications

The analysis showed inconsistent effect of KGF (keratinocyte growth factor). Because of the concern of cost and benefit, this is not strong evidence enough to recommend.

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Hansen, P.B., & Penkowa, M. (2017). Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: A randomised, double-blind, prospective pilot study. Supportive Care in Cancer, 25, 1279–1289.

Study Purpose

To study the effects of oral bismuth in patients prior to autologous stem cell transplantation on reducing the adverse effects of high-dose chemotherapy, including mucositis, neutropenia, and bacteremia.

Intervention Characteristics/Basic Study Process

Randomized, double-blind controlled study either to intervention or placebo group. Bismuth or placebo was 1,000 mg × 2 orally daily for 5 days, followed by 10 days with a daily dose of 500 mg × 2 orally. The first 5 days of bismuth or placebo treatment were prior to the start of chemotherapy regimens, which started on day −3 (multiple myeloma) and day −7 (lymphoma) before ASCT (day 0). The 10 days on the lower dose of bismuth or placebo also started on day −3 (multiple myeloma) and day −7 (lymphoma). On day +4, all patients received 6 mg pegfilgrastim to reduce neutropenia.

Sample Characteristics

  • N = 50   
  • AGE: 32-73 years
  • MALES: 66%  
  • FEMALES: 34%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma or lymphoma 
  • OTHER KEY SAMPLE CHARACTERISTICS: Autologous stem cell transplantation candidates

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Copenhagen, Denmark

Phase of Care and Clinical Applications

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

Study Design

  • Randomized, double-blind study to one of two groups receiving oral bismuth or a placebo 

Measurement Instruments/Methods

Laboratory results: Hemoglobin, leukocytes, differential count, thrombocytes, and reticulocytes. Stomatitis, diarrhea, fever, febrile neutropenia and documented infections based on the Common Criteria for Adverse Events, version 3.0.

Results

Results showed a reduction in grade 2 stomatitis, febrile neutropenia, and infections caused by high-dose chemotherapy. Bismuth reduced significantly the incidence of grade 2 stomatitis, as it occurred only in 2 of 13 patients (15%, two-tailed p = 0.001)

Conclusions

Oral bismuth is shown to be effective in certain patient groups. Oral bismuth may be effective in reducing high-dose chemotherapy effects of mucositis, neutropenia, and infections. The study indicates that there may be a gender difference in side effects; therefore, more studies are warranted to determine the impact of gender differences of treatment and prevention of cytotoxic effects of the treatment.

Limitations

Small sample (< 100)

 

Nursing Implications

First study to use this intervention in hematologic inpatients. More research is needed on the preventative properties of oral bismuth.

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