Calendula officinalis and matricaria chamomilla in the prevention and treatment of radiodermatitis in patients with head and neck cancer undergoing radiotherapy: randomized clinical trial.
Calendula; Chamomile; Head and Neck Neoplasms; Radiodermatitis; Oncology Nursing.
During radiotherapy, radiation is not limited to tumor cells, affecting adjacent tissues and promoting local and generalized adverse reactions, including: radiodermatitis. It is estimated that radiodermatitis affects around 80-90% of patients undergoing radiotherapy in the head and neck region. This study aims to evaluate the effects of topical creams on radiodermatitis in patients with head and neck cancer undergoing radiotherapy alone or combined with chemotherapy. This is a randomized, controlled and double-blind clinical trial, with a quantitative approach that will comply with the standards recommended by the Consolidated Standards of Reporting Trials. The present study will be carried out in the radiotherapy sector of the Advanced Oncology Center of the Liga Norte Riograndense Contra o Câncer. Research participants will be randomly allocated into three groups: a) Control group: will use topical cream with essential fatty acids; b) Experimental Group 1: will use topical Calendula cream; or c) Experimental Group 2: will use topical Chamomile cream. It was estimated that the sample will be 20 patients for each group (control and experimental), totaling 60 patients. The data collection instrument is subdivided into four parts: 1) Patient identification and sociodemographic data; 2) Clinical data and information regarding antineoplastic treatment; 3) Data regarding radiodermatitis according to the Radiation Therapy Oncology Group (RTOG) criteria and; 4) Data regarding pain according to the Visual Analogue Scale (VAS). The collected data will be stored and processed in a computerized database using Microsoft Office Excel and Statistical Package for the Social Sciences (SPSS) version 20.0 software.The research project will be forwarded to the Research Ethics Committee (CEP) for consideration, evaluation and authorization and registered on the Brazilian Clinical Trials Registry virtual platform (ReBEC).