Lakhani, R. (2017). A randomised double blind clinical trial to assess the effectiveness of topical application of aloe vera gel versus base gel on radiation-induced mucositis in patients receiving radiation therapy for head and neck malignancy in a selected hospital in Mumbai. Nursing Journal of India, 108, 187.

This study aims to evaluate the time of onset and severity of mucositis in the treatment arm (aloe vera gel) versus the control arm in patients receiving head and neck radiation. Additionally, this study describes demographic variables that impact the severity of mucositis in patient undergoing radiation therapy of the head and neck. Secondary outcomes also included a comparison of hospitalization rates, need for analgesia, antifungals, and antibiotics, as well as nutritional support rates, rates of treatment interruption, and weight loss. Quality-of-life differences between groups was also assessed.

1. Using block randomization, subjects were assigned to a treatment or control arm
2. For patients in both groups, patients applied a thin layer of gel (presumably to the oral mucosa) three times daily throughout their radiation treatment. Patients were told not to drink/eat anything for 15 minutes. The treatment group applied 10% aloe vera, the control group gel was not specified other than a “base gel.”
3. The patients in both groups were assessed on day 1, 8, 15, 22, 29, 36, and “last day.”

• N = 100, 51 in treatment group, 49 in control group   
• AGE: Adult, 10  participants were younger than age 40 years, 28 participants were 41-50 years, 31 participants were 51-60 years, and 31 participants were older than age 60 years
• MALES: 85%  
• FEMALES: 15%
• CURRENT TREATMENT: Combination radiation therapy and chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer undergoing radiation therapy or chemotherapy-radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included allergy to aloe vera, diabetes-mellitus, immune suppressants, and HIV-positive patients

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Mumbai, India

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

Randomized, double blind control study

• Data was collected using an interview schedule and an observational tool
• Primary outcomes: WHO grading of mucositis and VAS oral pain scores
• Secondary outcomes: Amount of antibiotic, antifungal, and analgesia used and on what day of treatment. Number of hospital admissions, nutritional support requirement, treatment interruption, weight loss, QOL: OMWQ-HN, and FACT-HN

Patients in the treatment group had later onset of mucositis (p < 0.05). The treatment group also had decreased severity of mucositis (p < 0.005). The treatment group had less weight loss and less need for supportive medications. The QOL measures were more favorable for the treatment group (p = 0.000 for OMWQ, p = 0.001 for FACT-HN). There was no difference between groups in hospitalization rates or the need for nutritional support. 

There is some discrepancy about oral pain results; the text says it was better in the treatment group but the p value listed is 0.243.

The author does not tell the reader anything about the statistical testing that was done, which limits the ability to interpret the results. The tables and charts are not completely labeled so they are hard to interpret as well.

• Measurement/methods not well described
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: The statistical analysis is poorly described. Most of the data is reported as frequency and percent of occurrence. Although the onset of occurrence of mucositis is significant (p = 0.043), there is only a difference of either 0.7, but it does not state if this is 0.7 days or hours (the mean is 17.5 in the treatment group, 16.8 in the control group). The authors provide a z score of 1.7 and a df of 98). As far as analgesic requirements, the authors do not provide data. On grades of mucositis, the table only report on the grade on the last day of therapy, and the p value may be representative of all grades; however, grades 1 and 2 are worse in the experimental group and grade 3 is worse in the control group. It is difficult to interpret the data because the x and y axes are not labeled. There is no mention of how compliant patients were with the protocol; therefore, there is potential for poor protocol fidelity (Did the aloe vera feel good and the base solution not? Did it taste better/worse so people didn’t use it? All of this is unknown). It is very hard to delineate the magnitude of group differences across time. Seeing the raw data may help answer these questions.

Aloe vera gel may help decrease the time to development and severity of radiation-induced mucositis in patients with head and neck cancer.