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

NCT ID: NCT07282483

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-05-31

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

Detailed Description

The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral liquid with a mouthwash in reducing the incidence, duration, and severity of mild-to-moderate radiation-induced oral mucositis (RIOM). The study addresses two main questions: (1) whether the combined TCM oral liquid and mouthwash can effectively mitigate RIOM and lower the incidence of severe RIOM, and (2) whether their use is associated with adverse events in patients receiving radiotherapy.

Participants will begin treatment on the first day mild-to-moderate RIOM (RTOG grade 1-2) occurs during radiotherapy. They will take Qingying oral liquid four times daily and use a modified Da Huang-Huang Lian Xiexin mouthwash six times daily in combination, or receive a matching placebo. The treatment will continue until two weeks after radiotherapy. After each administration, patients must avoid eating, drinking, or performing oral hygiene for at least 1 hour to maximize mucosal contact time.

The trial will compare the intervention and placebo groups to determine the potential benefits of the combined regimen for managing RIOM.

Conditions

Radiation-induced Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

radiotherapy

Intervention Type: RADIATION

All subjects underwent radical radiotherapy

Placebo oral solution and mouthwash

Group Type: PLACEBO_COMPARATOR

Placebo oral solution and mouthwash

Intervention Type: 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.

radiotherapy

Intervention Type: RADIATION

All subjects underwent radical radiotherapy

Interventions

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

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

Intervention Type: DRUG

Placebo oral solution and mouthwash

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.

Intervention Type: DRUG

radiotherapy

All subjects underwent radical radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;

2. Age range: 18 to 65 years old (including 18 and 65 years old);

3. Eastern Cooperative Oncology Group performance status of ≤2;

4. Radiotherapy or concurrent chemoradiotherapy is required;

5. The main organ functions well;

6. Sign informed consent.

Exclusion Criteria

1. Allergic constitution (such as those known to be allergic to two or more drugs);

2. 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;

3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;

4. Poor oral hygiene and/or severe periodontal diseases;

5. History of head and neck radiotherapy;

6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital

Chengdu, Sichuan, China

Countries

China

Central Contacts

Xingchen Peng, Professor

Role: CONTACT

pxx2014@163.com

+8618980606753

Jiayi Yu, Doctor

Role: CONTACT

yujiayi2209@163.com

+8618349376247

Facility Contacts

Xingchen Peng, Ph.D

Role: primary

pxx2014@163.com

+8618980606753

Other Identifiers

2024-1774

Identifier Type: -

Identifier Source: org_study_id