Ben-David, M.A., Elkayam, R., Gelernter, I., & Pfeffer, R.M. (2016). Melatonin for prevention of breast radiation dermatitis: A phase II, prospective, double-blind randomized trial. The Israel Medical Association Journal, 18, 188–192. Retrieved from https://www.ima.org.il/filesupload/imaj/0/193/96915.pdf
To evaluate a cream containing melatonin in terms of efficacy in reducing acute radiation dermatitis during and immediately after radiation therapy, and to examine patient-reported comfort during the study period
PHASE OF CARE: Active antitumor treatment
Phase II, prospective, double-blind, randomized
The researchers reported no significant difference in skin toxicity for both groups for the first four weeks of radiation treatment. The authors reported findings of significance in terms of reduced radiation dermatitis in the melatonin group at week five to seven (p = 0.049). After radiation was complete, the authors reported significant findings at the two-week follow-up visit in terms of reduced dermatitis in the melatonin group (p = 0.03). The researchers found no difference in the melatonin group and placebo group patient questionnaire reports of symptoms during treatment (including pain, burning, itching). Other analysis showed that women in the melatonin group who were older and smoked showed less radiation dermatitis (significance values p = 0.021 and p = 0.007). Four patients in the melatonin group sustained an allergic reaction limited to the treated skin, which required treatment with a topical and/or oral steroid.
Women with early stage breast cancer (stage 0–II) who are status postlumpectomy and undergoing daily radiation treatment for five weeks may experience reduced skin toxicity from the twice daily application of a melatonin containing cream to the treatment area.
As there is currently no consensus or evidence-based practice to follow for the treatment for radiation dermatitis, this study could be used to identify a treatment option and possibly specific product use in other institutions where radiation is delivered. Although this study was limited to women with breast cancer who had undergone lumpectomy, there could be utility in applying the melatonin cream to patients undergoing radiation therapy for other types of cancers (e.g., head and neck cancer).