Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients (the Alantel study)

Autor: E. Villegas-Becerril, C. Jimenez-Garcia, L.A. Perula-de Torres, M. Espinosa-Calvo, C.M. Bueno-Serrano, F. Romero-Ruperto, F. Gines-Santiago, M.C. Moreno-Manzanaro, J.J. Muñoz-Gavilan, G. Montes-Redondo, M.A. Quesada-Roman, M.C. Linares-Ramirez, J.M. Parras-Rejano, N. Muñoz-Alcaraz, M.D. Maestre-Serrano, E.M. Romero-Rodriguez
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Contemporary Clinical Trials Communications, Vol 39, Iss , Pp 101288- (2024)
Druh dokumentu: article
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2024.101288
Popis: Objectives: Radiation-induced dermatitis (RD) is one of the most common toxicities in radiation therapy (RT) patients. Corticosteroids, immunosuppressants, and natural products (NPs) have been used as treatment. The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment. Design: We conducted a controlled, randomized, double-blind clinical trial. Setting: Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain). Interventions: Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream. Main outcome measures: The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed. Results: Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. The incidence of RD was lower in the GTA (71.4%) than in the GTE (91.4%) after 4 weeks of follow-up (RR = 0.78; NNT = 5; p
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