Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02282839
• Date of registration: 31/10/2014
• Prospective Registration: Yes
• Primary sponsor: Taichung Veterans General Hospital
• Public title: Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation
• Scientific title: The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial
• Date of first enrolment: January 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02282839
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Shih-An Liu, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Head and neck cancer patients scheduled to receive radiotherapy with or without
chemotherapy

Exclusion Criteria:

- Prior radiotherapy to the head and neck region

- Severe liver or renal disease

- Reye's syndrome

- Allergy to glutamine

- Reluctant to join the study



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Head and Neck Cancer

Mucositis

Intervention(s)

Dietary Supplement: Glutamine

Dietary Supplement: Placebo

Primary Outcome(s)

Oral mucositis [Time Frame: 8 weeks]

Secondary Outcome(s)

Quality of life [Time Frame: 8 weeks]

Pain status [Time Frame: 8 weeks]

Secondary ID(s)

TCVGH-1047004C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors