RECRUITINGPhase 2INTERVENTIONAL

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

Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

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

DRUG

Zishui Daohuo oral liquid combined with Kujiu mouthwash

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

RADIATION

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.

Locations (1)

West China Hospital

Chengdu, Sichuan, China