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

Taichung Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: Mucositis; Head and Neck Cancer

Treatments: Dietary Supplement: Glutamine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02282839

TCVGH-1047004C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Study group

Active Comparator group

Description:

Oral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy

Treatment:

Dietary Supplement: Glutamine

Control group

Placebo Comparator group

Description:

Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy

Treatment:

Dietary Supplement: Placebo