Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer

Last updated: July 13, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Cancer

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT00003170
NCCTG-969256
NCI-P97-0127
CDR0000065974
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 129
Study Start date:
February 01, 1998
Estimated Completion Date:
June 30, 2003

Study 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.

Connect with a study center

  • Saskatchewan Cancer Agency

    Regina, Saskatchewan S4S 6X3
    Canada

    Site Not Available

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona 85259-5404
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61602
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa 52403-1206
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 10309-1016
    United States

    Site Not Available

  • Siouxland Hematology-Oncology

    Sioux City, Iowa 51101-1733
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • CentraCare Clinic

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • CCOP - Merit Care Hospital

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio 43623-3456
    United States

    Site Not Available

  • CCOP - Geisinger Clinical and Medical Center

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota 57105-1080
    United States

    Site Not Available

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