Sancai Fengsui Decoction for RTOM: A Multicenter RCT

NCT07692997 | Not Yet Recruiting Phase 2

• 1 other identifier: NFEC-2026-211
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Radiation-Induced Oral Mucositis (RTOM); Head and Neck Cancer; Oral Mucositis of RTOG Grade Greater Than 1

Keywords

Head and neck tumors; Radiation-induced oropharyngeal mucositis; Traditional Chinese Medicine (TCM) rehabilitation; phase II; double-blind; two-arm (1:1); clinical trial

Outcome Measures

Primary Outcomes (1)

• Pain relief rate in the oral cavity/oropharynx

  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).

  Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).

Secondary Outcomes (6)

• 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.

• 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.

• 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

Study Arms (2)

Sancai Fengshui Tang group

EXPERIMENTAL

Sancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks.

Drug: Sancai Fengsui Decoction

Placebo control group

PLACEBO COMPARATOR

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.

Drug: Placebo Group

Interventions

Sancai Fengsui Decoction DRUG

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.

Sancai Fengshui Tang group

Placebo Group DRUG

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.

Placebo control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Jian Guan, PhD

CONTACT

020-62787238Guanj@smu.edu.cn; Guanj@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07