Clinical trial · Interventional
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
NCT05040425CI-TRIAL-00053831unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zi-Yin-Liang-Ge-San | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chinese herbal medicine treatment
- interventionNames
- Drug: Zi-Yin-Liang-Ge-San
- type
- NO_INTERVENTION
- label
- Non-Chinese herbal medicine treatment
Primary outcomes (2)
- measure
- Degree of oral mucositis
- timeFrame
- During the radiotherapy course, up to 6 weeks
- description
- The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- measure
- Mucositis pain
- timeFrame
- During the radiotherapy course, up to 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven stage II-IV squamous HNC * Indication for radiotherapy or radio-chemotherapy * No history of antitumor therapies * No history of oral ulcer and salivary gland diseases * Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: \<20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Terminal cancer for which aggressive treatments were not suitable * Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit) * Uncontrolled psychiatric problems or altered mental status * Had received medications for other clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.