Sancai Fengsui Decoction for RTOM: A Multicenter RCT

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Jul 9, 2026

Start date

Aug 1, 2026

Status verified

Jul 2026

Primary completion

Jan 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sancai Fengshui Tang group
  Sancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks.
• Placebo Comparator: Placebo control group
  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 Measure

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). ]

Central Contacts

• Jian Guan, PhD
  [email protected]
  [email protected]

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