Sancai Fengsui Decoction for RTOM: A Multicenter RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sancai Fengsui Decoction, Placebo Group.
- Who it may be relevant to
- Registry conditions: Radiation-Induced Oral Mucositis (RTOM), Head and Neck Cancer, Oral Mucositis of RTOG Grade Greater Than 1. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
Overview
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.
Interventions
- Drug Sancai Fengsui Decoction
To investigate the efficacy of Sancai Fengsui Decoction in the treatment of RTOM，orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks. - Drug Placebo Group
The control group received a placebo that matched the color, odor, and taste of the Sancai Fengsui Decoction but contained no active ingredients of the decoction. The usage and dosage were the same as those in the Sancai Fengsui Decoction group.
Primary outcome measures
- Pain relief rate in the oral cavity/oropharynx [Time frame: Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).]
Secondary outcome measures (6)
- RTOG score remission rate of RTOM [Time frame: Evaluated at 2 weeks post-radiotherapy]
- 3-month xerostomia relief rate [Time frame: From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.]
- Analgesic medication use [Time frame: 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.]
- Usage of nutrient solutions/nutritional powders [Time frame: 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 [Time frame: 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 [Time frame: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10]
Eligibility criteria
Inclusion criteria
- 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.
- Exclusion Criteria:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07692997 · NFEC-2026-211