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

A Randomized Controlled Study of Houyanqing Oral Liquid Combined With Conventional Treatment Versus Conventional Treatment Alone for Preventing and Treating Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma

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.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation
• Locations: 16 sites (Beijing, Beijing Municipality and 15 other locations)
• Trial ID: NCT07311772 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with nasopharyngeal carcinoma (stage I–IV) who are scheduled for radical radiotherapy, have a Karnofsky score ≥80, and no pre-existing oral mucositis or prior head and neck radiotherapy.

Not a fit: Patients with recurrent or metastatic disease, prior head and neck radiotherapy, known allergy to the study drugs, or who cannot comply with follow-up are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If effective, the treatment could reduce the frequency and severity of mouth sores, lower pain and treatment interruptions, and improve quality of life during radiotherapy.

How similar studies have performed: Smaller clinical reports and preclinical data support Houyanqing's anti-inflammatory and mucosal-healing effects, but large randomized phase 3 evidence is limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 15 other locations

• 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)
• Cancer Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhengjiang, 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

Conditions Nasopharyngeal Cancinoma; Radiation-induced Oral Mucositis; Houyanqing Oral Liquid