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:	Villegas-Becerril E; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Maser Clinic, Cordoba, Spain., Jimenez-Garcia C; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Epidemiology Service, Cordoba-Guadalquivir Health District, 14011 Cordoba, Spain., Perula-de Torres LA; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Research Network on Chronicity, Primary Care and Prevention and Health Promotion RICAPS-ISCIII, Cordoba, Spain., Espinosa-Calvo M; Radiotherapy Oncology Service. Reina Sofia University Hospital, Cordoba, Spain., Bueno-Serrano CM; Radiotherapy Oncology Service. Reina Sofia University Hospital, Cordoba, Spain., Romero-Ruperto F; Radiotherapy Oncology Service. Reina Sofia University Hospital, Cordoba, Spain., Gines-Santiago F; Radiotherapy Oncology Service. Reina Sofia University Hospital, Cordoba, Spain., Moreno-Manzanaro MC; Radiotherapy Oncology Service. Reina Sofia University Hospital, Cordoba, Spain., Muñoz-Gavilan JJ; Lucano Clinical Management Unit, Cordoba-Guadalquivir Health District, Cordoba, Spain., Montes-Redondo G; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Cordoba-Guadalquivir Health District, Maimonides Institute for Biomedical Research (IMIBIC), Cordoba, Spain.; Santa Rosa Clinical Management Unit, Cordoba-Guadalquivir Health District, Cordoba, Spain., Quesada-Roman MA; Lucano Clinical Management Unit, Cordoba-Guadalquivir Health District, Cordoba, Spain., Linares-Ramirez MC; Santa Rosa Clinical Management Unit, Cordoba-Guadalquivir Health District, Cordoba, Spain., Parras-Rejano JM; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Huerta de la Reina Clinical Management Unit, Cordoba-Guadalquivir Health District, Maimonides Institute for Biomedical Research IMIBIC, Cordoba, Spain., Muñoz-Alcaraz N; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Support System of the Cordoba-Guadalquivir Health District, Maimonides Institute for Biomedical Research IMIBIC, Cordoba, Spain., Maestre-Serrano MD; Lucano Clinical Management Unit, Cordoba-Guadalquivir Health District, Cordoba, Spain., Romero-Rodriguez EM; Maimonides Institute for Biomedical Research IMIBIC, Cordoba University, 14004, Cordoba, Spain.; Cordoba-Guadalquivir Health District, Maimonides Institute for Biomedical Research (IMIBIC), Cordoba, Spain.
Jazyk:	angličtina
Zdroj:	Contemporary clinical trials communications [Contemp Clin Trials Commun] 2024 Apr 02; Vol. 39, pp. 101288. Date of Electronic Publication: 2024 Apr 02 (Print Publication: 2024).
DOI:	10.1016/j.conctc.2024.101288
Abstrakt:	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 < 0.031). The Skindex-29 questionnaire showed differences in the statement: "My skin condition makes it hard to work or do hobbies" (17.1% in the GTE vs. 2.9% in GTA; p = 0.024). Conclusions: The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Celia Jimenez Garcia reports financial support, administrative support, article publishing charges, and equipment, drugs, or supplies were provided by Fundación Progreso y Salud. Enrique Villegas Becerril has patent pending to EP23382729-4. (© 2024 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu