NCT00003170

Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer

Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Glutamine may be an effective treatment for acute diarrhea caused by radiation therapy. It is not known if glutamine is an effective treatment for acute diarrhea caused by radiation therapy. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are receiving radiation therapy.

Detailed description

OBJECTIVES: I. Determine whether glutamine is effective in reducing the acute treatment related diarrhea in patients receiving pelvic external beam radiation therapy as adjuvant or primary treatment of malignancy. II. Determine whether glutamine can reduce chronic treatment related enteropathy following completion of therapy. III. Determine whether glutamine causes any toxicity in this situation. IV. Provide initial reliability and validity data for a patient bowel function questionnaire. OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are stratified by history of anterior resection of the rectum (yes vs no); total planned cumulative dose, including boost fields of external beam radiotherapy (4500-5350 cGy vs 5350-6000 cGy vs greater than 6000 cGy); use of fluorouracil (none vs bolus vs continuous infusion); and primary site (rectal cancer vs prostate cancer vs gynecological cancer vs other). Beginning the first or second day of radiotherapy, patients receive either oral glutamine or a placebo twice daily, including the days that they do not receive radiotherapy. Patients continue on treatment throughout radiotherapy and continue 2 weeks postradiotherapy or until grade 3 diarrhea occurs. Patients are followed weekly for 4 weeks, then at 12 months, and then at 24 months after radiotherapy.

Conditions

• Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	glutamine
OTHER	placebo

Timeline

• Start date: 1998-02-01
• Primary completion: 2003-05-01
• Completion: 2003-06-01
• First posted: 2004-09-06
• Last updated: 2016-07-14

Locations

18 sites across 2 countries: United States, Canada