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

NCT02282839 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-11-04

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Glutamine

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282839 on ClinicalTrials.gov