A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Pain relief rate in the oral cavity/oropharynx
研究概览
简要总结
How to promote the prognosis and outcome of RTOM, restore oral function, and improve quality of life are key issues for improving the long-term outcomes of head and neck malignant tumor radiotherapy, and are also integral parts of the patient-centered Traditional Chinese Medicine "prevention-treatment-rehabilitation" system for RTOM. This project aims to thoroughly evaluate the efficacy and safety of Chinese herbal compounds in the rehabilitation phase of RTOM, targeting the long-term rehabilitation outcomes of RTOM, and to conduct a phase II clinical trial. In this project, Sancai Fengsui Decoction will be used as an oral medication to improve the rehabilitation status of RTOM, and will be compared with a placebo group. The efficacy of the oral medication will be evaluated by comparing outcome measures including the 2-week pain relief rate in the oral cavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate of xerostomia. As an important extension of TCM prevention and treatment for RTOM, this project can provide a high-level evidence-based TCM protocol for the long-term rehabilitation of RTOM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets the diagnostic criteria for RTOM, with severity classified according to the RTOG grading system;
- •Voluntarily participates in this study and signs the informed consent form;
- •Age between 18 and 65 years;
- •Histopathologically diagnosed with non-metastatic head and neck malignancy;
- •Has received radiotherapy or concurrent chemoradiotherapy;
- •ECOG performance status score: 0-2;
- •Adequate major organ function.
排除标准
- •Patients with severe heart, lung, liver, kidney, digestive system, hematopoietic system, or nervous system diseases; acute infectious diseases; autoimmune diseases; HIV; diabetes mellitus with poor blood glucose control; or any other serious condition that, in the investigator's judgment, may increase the risk of the study, interfere with study execution or result analysis, or make the subject unsuitable for enrollment for other reasons;
- •Pregnant or breastfeeding women;
- •Allergic constitution;
- •Patients with severe psychiatric disorders, or a history of alcohol or drug abuse;
- •Participation in another clinical trial within the past 3 months;
- •Subjects deemed unsuitable for participation in this clinical study by the investigator.
结局指标
主要结局
Pain relief rate in the oral cavity/oropharynx
时间窗: Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).
The proportion of patients achieving a clinically significant improvement in pain intensity from baseline to 2 weeks post-enrollment, as assessed by the Numeric Rating Scale (NRS). Complete response (CR) was defined as a pain score of 0 (no pain), and partial response (PR) was defined as either a reduction of at least 2 points from baseline on the NRS or an improvement by one pain category, according to the following NRS classification: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
次要结局
- Usage of nutrient solutions/nutritional powders(Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.)
- RTOG score remission rate of RTOM(Evaluated at 2 weeks post-radiotherapy)
- 3-month xerostomia relief rate(From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.)
- Analgesic medication use(Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30(Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35(Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10)