Chaitanya, B., Pai, K.M., Yathiraj, P.H., Fernandes, D., & Chhaparwal, Y. (2017). Rebamipide gargle in preventive management of chemo-radiotherapy induced oral mucositis. Oral Oncology, 72, 179–182.

DOI Link

Study Purpose

The aim of the study to evaluate the efficacy of a Rebamipide gargle in the prevention and treatment of chemoradiotherapy-induced oral mucositis.

Intervention Characteristics/Basic Study Process

All participants received bottles of gargle and were advised to gargle with 20 ml of gargle, six times a day (breakfast, 11 am lunch, 3 pm dinner, and at bedtime) beginning on the first day of radiotherapy and ending at the completion of radiotherapy. The gargle provided to both groups were identical in ingredients except for the one given to the intervention group, which contained an extra ingredient (Rebamipide). Daily oral exams were conducted at the beginning of radiotherapy and concluded at the end of radiotherapy to determine the onset of oral mucositis.

Sample Characteristics

  • N = 60 (n = 30 in intervention and control groups)    
  • AGE: 34-75 years
  • MALES: 98%    
  • FEMALES: 1%
  • KEY DISEASE CHARACTERISTICS: Participants were aged 18 years of age or older who were undergoing radiation therapy for newly diagnosed head and neck squamous cell carcinoma.
  • OTHER KEY SAMPLE CHARACTERISTICS: 13% had stage I/II cancer and 86% had stage III/IV cancer.

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified  
  • LOCATION: Unknown

Phase of Care and Clinical Applications

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

Study Design

Randomized, double-blinded placebo controlled study.

Measurement Instruments/Methods

Numeric scale and the RTOG grading system. Statistical methods used were the IBM SPSS Statistics, version 18, with comparison of variables done using an Independent sample t test and Mann-Whitney U test. Chi-square test was used to compare categorical variables.

Results

A statistically significant delay of onset of mucositis of 3.5 days was found in the intervention group as compared to the control group. A statistically significant reduction in numeric and RTOG pain scores were also found in the intervention group as compared to the control group.

Conclusions

Rebamipide gargle is effective in delaying the onset of oral mucositis and in reducing the severity of pain of oral mucositis in patient undergoing chemotherapy and radiation therapy for head and neck cancer.

Limitations

Small sample (< 100)

 

Nursing Implications

CAM 2028 can be effective in treating pain induced oral mucositis from radiation therapy. Benzydamine does not contribute to the reduction of oral mucositis pain.