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

Phase 3

• Conditions: Mucositis; Head and Neck Cancer
• Interventions: Dietary Supplement: Glutamine; Dietary Supplement: Placebo

• Registration Number: NCT02282839
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Study Start: 2015-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-04
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Glutamine	Oral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy
Control group	Placebo	Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy

Primary Outcome Measures

Name	Time	Method
Oral mucositis	8 weeks	According to WHO grading system

Secondary Outcome Measures

Name	Time	Method
Quality of life	8 weeks	Washington University Quality of life questionaire
Pain status	8 weeks	Pain status by visual analog scale

Trial Locations

Locations (1)

Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan