Clinical trial NCT02282839: Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation
Official title: The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Head and Neck Cancer
Mucositis
Keywords: Head and neck cancer
Glutamine
Oral mucositis
Quality of life
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Oral mucositis
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain status
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital
Study officials:
References:
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