NCT07692997Not yet recruitingPhase 2
Sancai Fengsui Decoction for RTOM: A Multicenter RCT
A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 7 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Head and neck cancer
- NCT number
- NCT07692997
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From 1 Aug 2026 to the primary completion date, 31 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.