Use of Topical Calendula and Chamomile Creams for the Management of Radiodermatitis in Cancer Patients: A Randomized Clinical Trial Protocol

Background: Radiodermatitis is a common skin injury in patients undergoing radiotherapy, especially in cases of head and neck cancer, and may impair treatment adherence and the patient's quality of life. Therefore, the search for effective and low-cost interventions for the prevention and management of radiodermatitis is essential. In this context, Calendula- and Chamomile-based creams have been considered in oncological care. Objective: To evaluate the effectiveness of topical Calendula and Chamomile creams in the prevention and treatment of radiodermatitis in head and neck cancer patients undergoing radiotherapy combined with chemotherapy. Methods: This is a protocol for a randomized, controlled, triple-blind clinical trial employing a quantitative approach. The protocol adheres to the guidelines advocated by the Consolidated Standards of Reporting Trials (CONSORT) 2025 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025. A total of 99 participants will be randomly allocated into 3 groups. Data will be collected using a four-section instrument and analyzed with Microsoft Office Excel and Statistical Package for Social Sciences (SPSS) version 20.0. Results: This study aims to validate the effectiveness of Calendula and Chamomile creams in controlling radiodermatitis and to identify the most efficient option for preventing adverse effects. Conclusion: The findings are expected to underscore the necessity of promoting and implementing systematic, scientifically grounded protocols in oncological patient care, emphasizing a humanized approach. Trial and Protocol Registration: Brazilian Registry of Clinical Trials (ReBEC), RBR-8gxt823, https://ensaiosclinicos.gov.br/rg/RBR-8gxt823.