Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation
Conditions
Head and Neck Cancer - Mucositis
Conditions: official terms
Head and Neck Neoplasms - Mucositis
Conditions: Keywords
Head and neck cancer, Glutamine, Oral mucositis, Quality of life
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Glutamine Type: Dietary Supplement
Name: Placebo Type: Dietary Supplement
Overall Status
Recruiting
Summary
This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine during radiotherapy while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system), pain status (visual analogue scale), quality of life questionnaires will also be documented. The differences between the two groups will be analyzed.
Detailed Description
Chemotherapy and radiotherapy are important therapeutic modalities for head and neck cancer patients. Oral mucositis is a common comorbidity during chemotherapy and radiotherapy. It was reported that 30-60% of patients underwent chemotherapy and over 90% of patients receiving radiotherapy had oral mucositis. Oral mucositis not only reduces the quality of life of cancer patients during therapy but also causes dysphagia and poor nutritional status. Severe oral mucositis may necessitate unplanned gaps between treatment which can undermine the chance of local control.

In terms of management of oral mucositis, maintaining of oral hygiene and avoid infection are essential manner. Topical agents such as sucralfate, benzydamine, antifungal drugs, vitamin E and treatment using laser were studied in the management of oral mucositis. Previous studies indicated the glutamine significantly reduced the incidence and severity of oral mucositis in patients underwent chemotherapy and bone marrow transplantation. However, few studies discussed the effect of glutamine on the impact of oral mucositis in head and neck cancer patients receiving radiotherapy with/without chemotherapy.

This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system, every week), pain status (visual analogue scale, every week), quality of life questionnaires (before, during and after radiotherapy) will also be documented. The differences between the two groups will be analyzed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital
Taichung, Taiwan
Status: Recruiting
Contact: Shih-An Liu, MD - +886-4-23592525 - saliu@vghtc.gov.tw
Start Date
January 2015
Completion Date
December 2016
Sponsors
Taichung Veterans General Hospital
Source
Taichung Veterans General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page