Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

NCT07282483 | Recruiting Phase 2

• 1 other identifier: 2024-1774
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies

Conditions

Radiation-induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Incidence rate 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 the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks

Secondary Outcomes (5)

• Duration of mild-to-moderate RIOM

  From the start of radiotherapy to 8 weeks after the end 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.

• RIOM remission rates at 4 and 8 weeks after completion of radiotherapy

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

• Duration of 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.

• 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

  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).

• Mouth and throat soreness (MTS) 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)

Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash

ACTIVE COMPARATOR

Drug: Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash; Radiation: radiotherapy

Placebo oral solution and mouthwash

PLACEBO COMPARATOR

Drug: Placebo oral solution and mouthwash; Radiation: radiotherapy

Interventions

Placebo oral solution and mouthwash DRUG

A placebo matched in color, odor, and taste to the Qingying oral liquid and the modified Da Huang-Huang Lian Xiexin mouthwash, but containing no active medicinal ingredients.

Placebo oral solution and mouthwash

radiotherapy RADIATION

All subjects underwent radical radiotherapy

Placebo oral solution and mouthwash; Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash

Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash DRUG

Classical traditional Chinese medicine (TCM) formulations provided as an oral liquid and a herbal mouthwash

Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash

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

Central Study Contacts

Xingchen Peng, Professor

CONTACT

+8618980606753; pxx2014@163.com

Jiayi Yu, Doctor

CONTACT

+8618349376247; 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: PhD, Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)