Cancer Clinical Trial
Official title:
Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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