Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer

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.

DISEASE CHARACTERISTICS: Histologically confirmed pelvic cancer Planned therapy is to
undergo continuous definitive or adjuvant external beam pelvic radiation therapy with or
without fluorouracil (5-FU) plus or minus levamisole No split course radiation therapy
Planned course of radiation therapy must also meet the following criteria: - Entire pelvis
must be encompassed by the planned radiotherapy fields - Total planned dose to the central
axis midplane or isocenter for the whole pelvic field must be between 4500-5350 cGy -
Treatment must be given 4-5 times per week on a one-treatment-per-day basis No stool
incontinence or stool frequency of 7 or more per day prior to initiation of radiation
therapy Must be entered on study before the second radiation therapy fraction No current
or prior metastases beyond pelvic regional lymph nodes Must have functioning rectum No
planned perineal irradiation No anal cancer No active intraluminal gastrointestinal (GI)
tumors Patients with completely resectioned GI tumors who also receive adjuvant treatment
are eligible

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less
than 2 times upper limit of normal Other: No known allergy to glutamine No history of
inflammatory bowel disease No other medical condition that may interfere with treatment
Not pregnant or nursing Adequate contraception is required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
leucovorin or other chemotherapy agents, except 5-FU with or without levamisole Endocrine
therapy: Not specified Radiotherapy: See Disease Characteristics No prior pelvic
radiotherapy No brachytherapy prior to completion of all external beam radiotherapy
Surgery: No abdominal-perineal resection, Hartmann procedure, or other surgical procedure
that has left patient without a functioning rectum