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NCT Number: NCT07692997

Sancai Fengsui Decoction for RTOM: A Multicenter RCT

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

    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).

Secondary outcomes

  1. RTOG score remission rate of RTOM

    Time frame: Evaluated at 2 weeks post-radiotherapy

    The proportion of patients with a reduction of at least 1 grade in mucosal reaction at 2 weeks after radiotherapy, according to the RTOG acute radiation morbidity grading criteria (complete response defined as return to grade 0, partial response as reduction by at least 1 grade).

  2. 3-month xerostomia relief rate

    Time frame: From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.

    To evaluate the proportion of patients who achieve a clinically significant improvement in subjectively reported xerostomia severity over the 3-month period, as assessed by the xerostomia questionnaire.

  3. 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.

    By reviewing patients' medication diaries and medical records, we analyzed changes in the average daily dosage and frequency of analgesic use, as well as cases of dose reduction or drug discontinuation.

  4. 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.

    Consumption records of nutritional support products were collected to analyze the proportion of patients dependent on enteral nutrition support, as well as changes in usage volume and duration

  5. 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

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its head and neck cancer module (QLQ-H&N35) were adopted to evaluate the improvement in overall quality-of-life scores and scores of specific domains (e.g., fatigue, swallowing function)

  6. 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

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its head and neck cancer module (QLQ-H&N35) were adopted to evaluate the improvement in overall quality-of-life scores and scores of specific domains (e.g., fatigue, swallowing function)

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Guan, PhD

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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