[Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial]

ABSTRACT

Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment [30], and the other received the new treatment, 0.1% calendula ointment [30]. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was 0, 6.7%; I, 73.3%; II, 16.7%; III, 0%; IV, 3.3%. Dermatitis intensity in the calendula group was 0, 13.3%; I, 67%; II, 16.7%; III, 0%; IV, 3.3%. No significant differences were observed in the incidence of symptoms such as burning, pruritus and pain between the two groups [p=0.762]. Calendula ointment is as effective as betamethasone in reducing acute radiation dermatitis