Traditional Chinese oral solution and mouthwash to shorten severe radiation-induced mouth sores in head and neck cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2 trial enrolls adults with non-metastatic head and neck cancer who develop severe radiation-induced oral mucositis (RTOG grade ≥3) during radiotherapy. Participants start treatment the first day severe mucositis appears and receive Zishui Daohuo oral solution three times daily plus Kuju mouthwash six times daily, or matched placebos. Treatment continues until two weeks after radiotherapy, and patients are asked to avoid eating, drinking, or oral hygiene for one hour after each use to maximize mucosal contact. Primary outcomes include duration of severe mucositis and safety/adverse events compared between the TCM combination and placebo groups.

Why it matters

Who can join: the full rules

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).

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Xingchen Peng, Professor — West China Hospital
• Study coordinator: Xingchen Peng Professor
• Email: pxx2014@163.com
• Phone: +8618980606753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using breath analysis to predict mouth sores from radiotherapy in head and neck cancer patients

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• Assessing SAA1 Levels to Predict Oral Mucositis from Radiotherapy

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  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong and 4 other locations · NCT06307314

• Houyanqing oral liquid to prevent and treat radiation mouth sores in nasopharyngeal cancer

  This phase 3 trial will test whether adding Houyanqing oral liquid to standard care can prevent or lessen radiation-caused mouth sores in adults receiving radiotherapy for nasopharyngeal cancer.

  Recruiting at 16 sites Phase 3 Sun Yat-sen University · Beijing, Beijing Municipality and 15 other locations · NCT07311772

• TCM oral liquid plus herbal mouthwash for radiation‑caused mouth sores in head and neck cancer

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  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07282483

• Rice bran for radiation-related mouth sores in head and neck cancer

  This trial will try rice bran supplements during radiation to see if adults with head and neck cancer have fewer or less severe mouth sores.

  Recruiting German University in Cairo · Cairo · NCT07242859

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.