Su, C.K., Mehta, V., Ravikumar, L., Shah, R., Pinto, H., Halpern, J., … Quynh-Tu, L. (2004). Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms. International Journal of Radiation Oncology, Biology, Physics, 60, 171–177.

DOI Link

Intervention Characteristics/Basic Study Process

Patients were given 20 mL aloe vera solution or placebo to swish and swallow four times per day beginning on the first day of radiation therapy (RT) and continuing throughout the treatment course. The  solution consisted of 94.5% aloe juice, 5.0% pear juice concentrate, 0.4% lemon-lime flavor, and 0.1% citric acid. The placebo solution was taste-matched with identical astringency, consistency, and ingredients, except that the aloe vera juice was replaced with water.

Sample Characteristics

The study reported on 58 patients with stage II-IV M0 head and neck cancer who were scheduled to receive radiation of at least 50 Gy to at least one site; 28 patients were given aloe vera, and 30 were given placebo.

Setting

The study was conducted from February 1999 through March 2002.

Study Design

This was a double-blind, placebo-controlled, randomized trial.

Measurement Instruments/Methods

  • Researchers recorded incidence and duration of mucositis.
  • Secondary endpoints were quality of life (QOL), weight loss, use of pain medications, need for IV hydration, oral infections, and duration of treatment interruptions.
  • The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and patient-completed QOL questionnaires were completed every two weeks.

Results

  • The aloe vera arm recorded a lower maximal mucositis severity grade; however, the difference was not statistically significant.
  • Incidence of grade 2 or worse mucositis was not statistically significant between the groups. The treatment group had lower QOL scores, but the differences were not significant.
  • Both arms had similar outcomes for other dimensions.
  • The authors concluded that the addition of aloe vera did not improve tolerance to head-and-neck RT; decrease objective measurements of mucositis; or improve QOL ratings of health, soreness, or well-being.

Conclusions

Findings were not significant.

Limitations

This study did not accrue adequate patients according to statistical analysis.