Ben-David MA, Elkayam R, Galarenter I, et al. A prospective, double-blind, randomized study of a melatonin-containing cream for radiation-induced breast dermatitis. American Society of Clinical Oncology Breast Cancer Symposium (ASCO Breast) 2010; Abstract 123. National Harbor, Maryland, October 2010.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&c...
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Author(s):
M. A. Ben-David, R. Elkayam, I. Galarenter, R. M. Pfeffer; Sheba Medical Center, Ramat-Gan, Israel; Biostatistics Department, Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel; Chaim Sheba Medical Center, Ramat-Gan, Israel
Abstract:
Background: Radiation induced acute skin reactions are common during adjuvant radiotherapy for breast cancer (BC). Melatonin based creams have shown a protective effect against ultraviolet induced erythema and melatonin demonstrated radioprotective effects in rats. As skin is not a target, protecting it from radiation will result in less dermatitis and discomfort during RT. The primary end point was to evaluate the efficacy of melatonin containing cream (Praevoskin, PraevoMed GmbH, Germany) in minimizing acute radiation dermatitis compared to placebo (cream with no melatonin). This is an IRB approved, prospective randomized, placebo controlled double blind study. Methods: Between May and October 2009, 47 women who underwent lumpectomy and axillary evaluation for stage 0/1/2 BC signed informed consent and were randomly allocated to application of melatonin cream (26 women) or placebo (21 women) BID during RT period. All women received 50Gy whole breast RT with 2Gy/fx at the Sheba Medical Center, Israel, using CT based 3D planning. Median age was 54, with no difference between the groups regarding histology, stage, treatment, skin color, BMI, separation and axillary surgery. Patients were examined, photographed and completed a detailed questionnaire weekly and 2 weeks following RT. RTOG skin toxicity score was recorded. Results: The occurrence of grade 1/2 acute dermatitis was significantly lower (59% v 90%; p=0.038) in the melatonin group immediately following RT period. The difference was specifically noted in women older then 50, with only 56% having grade 1/2 in the melatonin group v 100% in the placebo; p=0.021. Moreover, interaction between time and groups reveals better RTOG scores for the melatonin in smokers, p=0.007. Maximal dermatitis was grade 2, recorded in only 15% (7 patients). Conclusions: This small study shows promising results for the melatonin containing cream in preventing radiation induced skin reactions. The incidence of grade 2 dermatitis in both arms in our study was lower than that reported in previously published studies. We are therefore planning a larger phase III study comparing the melatonin containing cream with a commercially available skin preparation.