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

Sichuan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Radiotherapy-induced Oral Mucositis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07339774

2024(1774)

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Zishui Daohuo oral liquid combined with Kujiu mouthwash group.

Experimental group

Treatment:

Radiation: Radiotherapy

Drug: Zishui Daohuo oral liquid combined with Kujiu mouthwash

Placebo oral liquid and mouthwash

Placebo Comparator group

Treatment:

Radiation: Radiotherapy

Drug: Placebo oral liquid and mouthwash