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

NCT ID: NCT07339774

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-10-30

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.

Detailed Description

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

Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time.

The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.

Conditions

Radiotherapy-induced Oral Mucositis

Study Design

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

Study Groups

Zishui Daohuo oral liquid combined with Kujiu mouthwash group.

Group Type: EXPERIMENTAL

Zishui Daohuo oral liquid combined with Kujiu mouthwash

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo oral liquid and mouthwash

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: 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.

Interventions

Placebo oral liquid and mouthwash

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

Intervention Type: DRUG

Zishui Daohuo oral liquid combined with Kujiu mouthwash

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

Intervention Type: DRUG

Radiotherapy

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.

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

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingchen Peng, Professor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

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

Facility Contacts

Xingchen Peng Ph.D

Role: primary

pxx2014@163.com

18980606753

Other Identifiers

2024(1774)

Identifier Type: -

Identifier Source: org_study_id