一项开放标签随机对照试验方案：评估Siddha附加方案治疗头颈癌患者放射性口腔黏膜炎

文献信息

中文摘要

背景： 放射性口腔黏膜炎（RIOM）是接受放疗或同步放化疗的头颈癌患者中常见且具有临床意义的并发症。它可导致严重的口腔疼痛、吞咽困难、营养障碍、继发感染和治疗中断，从而影响治疗依从性和肿瘤学结局。由于当前的标准治疗（SOC）主要侧重于症状缓解，因此需要可能改善患者整体结局的综合治疗方法。本研究设计为一项随机对照II期优效性试验，纳入160名参与者，每个研究组分配80名参与者。对照组参与者将接受每日六次苯达明漱口水作为SOC，而干预组参与者将在SOC基础上接受Siddha制剂，如Thiripala Chooranam漱口水和Gungiliya Vennai局部应用，每日三次。肿瘤科医生将使用经过验证的工具进行每周评估，包括放射治疗肿瘤学组（RTOG）口腔黏膜炎量表、WHO口腔黏膜炎量表、口腔疼痛视觉模拟量表（VAS）和WHO三阶梯止痛原则。本研究的主要结局是使用RTOG分级量表评估RIOM严重程度。次要结局包括使用WHO口腔黏膜炎量表评估黏膜炎严重程度、通过VAS评估口腔疼痛减轻（至少减少2分）、基于WHO三阶梯止痛原则的镇痛药使用、安全性结局和治疗中断。本研究可能为基于Siddha的综合方法在减轻接受头颈癌放疗患者的RIOM严重程度和改善支持性护理方面的有效性和安全性提供证据。临床试验注册：https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ2MTYw&Enc=&userName=，已在印度临床试验注册中心注册（CTRI/2025/12/098832- 注册于2025年12月10日）。试验的参与者招募已开始，研究目前正在进行中。

英文摘要

UNLABELLED: Radiation-induced oral mucositis (RIOM) is a common and clinically significant complication in patients undergoing radiotherapy or concurrent chemoradiotherapy for head and neck cancers. It can cause severe oral pain, dysphagia, nutritional compromise, secondary infections, and treatment interruptions, thereby affecting treatment compliance and oncological outcomes. Since the current standard of care (SOC) mainly focuses on symptomatic relief, there is a need for integrative treatment approaches that may improve overall patient outcomes. The present study is designed as a randomised controlled Phase II superiority trial involving 160 participants, with 80 participants allocated to each study arm. Participants in the control arm will receive benzydamine mouthwash six times daily as SOC, while those in the intervention arm will receive Siddha formulations such as Thiripala Chooranam mouthwash and Gungiliya Vennai topical application three times daily in addition to SOC. Weekly assessments will be carried out by oncologists using validated tools including the Radiation Therapy Oncology Group (RTOG) Oral Mucositis Scale, WHO Oral Mucositis Scale, Visual Analogue Scale (VAS) for oral pain, and WHO three-step analgesic ladder. The primary outcome of the study is the assessment of RIOM severity using RTOG grading scale. Secondary outcomes include evaluation of mucositis severity using the WHO Oral Mucositis Scale, reduction in oral pain assessed by VAS (minimum 2-point reduction), analgesic usage based on the WHO three-step analgesic ladder, safety outcomes, and treatment interruptions. This study may provide evidence on the effectiveness and safety of an integrative Siddha-based approach in reducing RIOM severity and improving supportive care in patients undergoing radiotherapy for head and neck cancers.
CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ2MTYw&Enc=&userName=, Registered in Clinical Trial Registry, India (CTRI/2025/12/098832- registered on 10-12-2025). Participant enrolment for the trial has commenced, and the study is currently ongoing.