Houyanqing oral liquid to prevent and treat radiation mouth sores in nasopharyngeal 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 phase 3, multicenter randomized controlled trial will compare Houyanqing Oral Liquid plus conventional treatment versus conventional treatment alone in patients with nasopharyngeal carcinoma receiving radical radiotherapy. Participants aged 18–75 with stage I–IV disease and good performance status will be randomized and followed through radiotherapy to monitor the onset, severity, and duration of radiation-induced oral mucositis. Primary outcomes include incidence and grade of mucositis, with secondary outcomes such as oral pain, ulcer healing time, radiotherapy interruptions, and quality of life. The trial uses established clinical grading and patient-reported measures across several leading oncology centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Staged as Stage I-IV according to the 9th edition of the TNM Classification of Malignant Tumors formulated by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC);
2. Age: 18 to 75 years old;
3. Karnofsky Performance Status (KPS) score ≥ 80 before treatment;
4. No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy;
5. Requiring radical radiotherapy;
6. The patient has signed the informed consent form and is willing and able to comply with the study's follow-up visits, treatment plan, laboratory tests, and other research procedures.

Exclusion Criteria:

1. Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments;
2. Previous history of head and neck radiotherapy;
3. Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs);
4. Local use of Houyanqing Oral Liquid, Recombinant Human Epidermal Growth Factor (rhEGF) Topical Solution, Vitamin B12 Solution, or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) mouthwash in the oral cavity within one month before enrollment;
5. Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local use of corticosteroids at immunosuppressive doses before enrollment;
6. HIV-positive patients;
7. Pregnant women or lactating women;
8. Patients with severe mental illnesses;
9. Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.

Where it's running

• Cancer Hospital Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Cancer Hospital of Shantou University Medical College
  Shantou, Guangdong, China Recruiting
• Fifth Affiliated Hospital of Sun Yat-sen University
  Zhuhai, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ming-Yuan Chen, MD, PhD — Fifth Affiliated Hospital of Sun Yat-sen University
• Study coordinator: Ming-Yuan Chen, MD, PhD
• Email: chmingy@mail.sysu.edu.cn
• Phone: 86-13903052650

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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.