Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.

NCT07339774 | Recruiting Phase 2

• 1 other identifier: 2024(1774)
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.

Conditions

Radiotherapy-induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• The duration of severe oral mucositis (RTOG grade≥3)

  The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

Secondary Outcomes (5)

• The time to onset of severe oral mucositis (RTOG grade≥3)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The duration of any-grade oral mucositis (OM)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The time to onset of any-grade oral mucositis (OM)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• Relief rate of oral mucositis

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• Adverse events

  From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.

Other Outcomes (8)

• The longitudinal dynamics of salivary microbiota

  1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks).

• Analysis of Inflammatory Indicators in Oral Saliva

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

• Oral activities scores

  The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6.5 weeks.

Study Arms (2)

Zishui Daohuo oral liquid combined with Kujiu mouthwash group.

EXPERIMENTAL

Drug: Zishui Daohuo oral liquid combined with Kujiu mouthwash; Radiation: Radiotherapy

Placebo oral liquid and mouthwash

PLACEBO COMPARATOR

Drug: Placebo oral liquid and mouthwash; Radiation: Radiotherapy

Interventions

Placebo oral liquid and mouthwash DRUG

Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients

Placebo oral liquid and mouthwash

Zishui Daohuo oral liquid combined with Kujiu mouthwash DRUG

Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.

Zishui Daohuo oral liquid combined with Kujiu mouthwash group.

Radiotherapy RADIATION

One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Placebo oral liquid and mouthwash; Zishui Daohuo oral liquid combined with Kujiu mouthwash group.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• Age range: 18 to 65 years old (including 18 and 65 years old);
• Eastern Cooperative Oncology Group performance status of ≤2;
• Radiotherapy or concurrent chemoradiotherapy is required;
• The main organ functions well;
• Sign informed consent.

You may not qualify if:

• Allergic constitution (such as those known to be allergic to two or more drugs);
• Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
• Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
• Poor oral hygiene and/or severe periodontal diseases;
• History of head and neck radiotherapy;
• Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

Mouthwashes; Radiotherapy

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Therapeutics

Study Officials

• Xingchen Peng, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng Professor

CONTACT

+8618980606753; pxx2014@163.com

JiaYi Yu Doctor

CONTACT

yujiayi2209@163.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 14, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)