为了评估含有姜黄素和红掌草提取物（FITOPROT）的粘附性草药治疗方法与光生物调节治疗（PBM）和预防性口腔护理计划（POCP）相比，在放疗（RT）引起的口腔粘膜炎（ROM）的治疗和患者的生活质量中的效果。进行了一项双盲临床试验，对象为进行放疗或放化疗的头颈癌患者。参与者被随机分为两组：第一组（n=27）：PBM和POCP；第二组（n=25）：PBM、POCP和FITOPROT。PBM方案为每天辐照，波长660纳米，功率25毫瓦，每点疗量0.25焦耳，从放疗开始一直到最后一天。FITOPROT作为漱口液，每天用两次。ROM根据世界卫生组织和美国国家癌症研究所的评估标准进行评估。生活质量使用华盛顿大学问卷、OHIP-14问卷和患者报告的口腔粘膜炎症状评估量表进行评估。使用MMAS-8问卷评估对POCP和FITOPROT的依从性。数据在基线、第7、第14、第21和第30次放疗时收集。在ROM评估中，两组之间没有统计学差异。两组在放疗期间都出现了生活质量恶化。在评估的任何工具中，两组之间没有统计学显著差异。结果表明，PBM结合FITOPROT和POCP可以控制ROM的严重程度并稳定头颈癌患者的生活质量。巴西临床试验登记（ReBEC-RBR-9vddmr；UTN编号：U1111-1193-2066），于2017年8月8日登记。© 2023年。作者（姓名），在Springer-Verlag GmbH Germany的独家许可下，Springer Nature的一部分。

To assess the effect of a mucoadhesive herbal medicine containing curcuminoids and a glycerinated extract of Bidens pilosa L. (FITOPROT) in association with photobiomodulation (PBM) therapy and a Preventive Oral Care Program (POCP) compared to PBM and POCP in the treatment of radiotherapy (RT)-induced oral mucositis (ROM) and in the quality of life of these patients.A double-blind clinical trial was performed with head and neck cancer patients undergoing RT or chemoradiotherapy. Participants were randomized into two groups: Group 1 (n=27): PBM and POCP; and Group 2 (n=25): PBM, POCP and FITOPROT. The PBM protocol was daily irradiation, 660 nm, 25mW, 0.25 J/point from the first until the last day of RT. The FITOPROT was used as mouthwash twice a day. ROM was evaluated based on the scales of the World Health Organization and National Cancer Institute. The quality of life was evaluated using the University of Washington Questionnaire, OHIP-14 and Patient-Reported Oral Mucositis Symptom Scale. The MMAS-8 questionnaire was used to evaluated the adherence to POCP and FITOPROT. Data were collected at baseline, 7th, 14th, 21st, and 30th RT sessions.No statistical differences were found between the groups for the ROM evaluation. Both groups experienced worsening of the quality of life during the RT. No statistically significant differences between groups were observed for any of the instruments evaluated.The results suggest that PBM associated with FITOPROT and POCP control the severity of ROM and stabilize the QoL of patients with head and neck cancer.Brazilian Registry of Clinical Trials (ReBEC-RBR-9vddmr; UTN code: U1111-1193-2066), registered in August 8th, 2017.© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.