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

The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02282839
Enrollment
60
Registered
2014-11-04
Start date
2015-01-31
Completion date
2017-12-31
Last updated
2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Mucositis

Keywords

Head and neck cancer, Glutamine, Oral mucositis, Quality of life

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.

Interventions

DIETARY_SUPPLEMENTGlutamine

Powder that soluble in water for drinking, 10g TID (total 30 g per day)

DIETARY_SUPPLEMENTPlacebo

Powder that provided by manufacturer with the same ingredients yet without glutamine, TID use

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oral mucositis8 weeksAccording to WHO grading system

Secondary

MeasureTime frameDescription
Pain status8 weeksPain status by visual analog scale
Quality of life8 weeksWashington University Quality of life questionaire

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026