Head and neck tumor
Conditions
Interventions
Control Group:Conventional treatment + Chinese herbal placebo
Experimental Group:Routine treatment + Yu Dong Jie Du Ning Granules
Sponsors
Hunan Province Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, gender, informed consent, voluntary participation in this study, with good compliance and communication skills; 2. Confirmed by histopathology as primary nasopharyngeal carcinoma or oral squamous cell carcinoma; 3. Patients according to the 2025 CSCO guidelines: - Nasopharyngeal carcinoma: Non-metastatic localized stage (I, II, and III stage with T1-3, N0-1, M0), or locally advanced but still in the radiotherapy-dominated treatment phase; - Oral cancer: T1-2N0 (postoperative adjuvant radiotherapy) or T3-4N0-2 but unable to undergo surgery,; 4. Planned total irradiation dose =66 Gy, treatment course of 6 weeks; 5. ECOG performance status score 0-2, Karnofsky performance status score =70, expected survival =6 months; 6. Laboratory tests indicate good function of major organs (no significant dysfunction in liver, kidney, heart, etc.); 7. VAS score <3 before radiotherapy, or although with pain, no continuous analgesic intervention; 8. Agree to undergo follow-up, complete pain assessment (VAS/NRS), TCM syndrome evaluation, and quality of life questionnaire records during the entire treatment period, during treatment, and within 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Combined non-regional distant metastasis (nasopharyngeal carcinoma stage IV C, oral cancer stage M1) or recurrent/secondary tumors; 2. History of radiotherapy in the head and neck region or currently participating in other interventional clinical studies; 3. Intended use of analgesic adjunct drugs (Amifostine) during radiotherapy or currently using Chinese herbal injections that may interfere with this study; 4. History of moderate to severe chronic pain in the oral cavity, throat, or face prior to radiotherapy; 5. Combined immune-related oral mucosal diseases or infectious oral ulcers; 6. Mental or neurological diseases (e.g., epilepsy, severe anxiety, or depression) affecting pain assessment and compliance; 7. Presence of significant oral administration obstacles without a nasogastric tube or enteral nutrition support (affecting Chinese herbal intervention); 8. Combined HIV infection, or active infection with HBV DNA or HCV RNA positivity; 9. Combined bleeding tendency or currently undergoing anticoagulation therapy; 10. Pregnant, breastfeeding women, or those planning pregnancy in the near future; 11. Receipt of systematic traditional Chinese medicine external treatment, Chinese herbal intervention, or continuous analgesic treatment within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Overall Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropathic pain;Quality of life;Mood and Sleep; | — |
Countries
China
Contacts
Public ContactPuhua Zeng
Hunan Province Institute of Traditional Chinese Medicine
Outcome results
None listed