Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Criteria

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