PHASE-III DOUBLE-BLIND EVALUATION OF AN ALOE VERA GEL AS A PROPHYLACTIC AGENT FOR RADIATION-INDUCED SKIN TOXICITY

Purpose: Considerable pilot data and clinical experience suggested tha t an aloe vera gel might help to prevent radiation therapy-induced der matitis. Methods and Materials: Two Phase III randomized trials were c onducted. The first one was double blinded, utilized a placebo gel, an d involved 194 women receiving breast or chest wall irradiation. The s econd trial randomized 108 such patients to aloe vera gel vs. no treat ment. Skin dermatitis was scored weekly during both trials both by pat ients and by health care providers. Results: Skin dermatitis scores we re virtually identical on both treatment arms during both of the trial s. The only toxicity from the gel was rare contact dermatitis. Conclus ions: This dose and schedule of an aloe vera gel does not protect agai nst radiation therapy-induced dermatitis. Copyright (C) 1996 Elsevier Science Inc.