Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003170
First received: November 1, 1999
Last updated: September 29, 2012
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Cancer
Dietary Supplement: glutamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 120
Study Start Date: February 1998
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 postradiotherpy or until grade 3 diarrhea occurs. Patients are followed weekly for 4 weeks, then at 12 months, and then at 24 months after radiotherapy.

PROJECTED ACCRUAL: A minimum of 120 fully evaluable patients (60 in each arm) will be accrued in one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003170

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States, 58501
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Canada, Saskatchewan
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada, S4S 6X3
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Timothy F. Kozelsky, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Kozelsky T, Martenson J, Sloan J, et al.: Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1540, 2001.

ClinicalTrials.gov Identifier: NCT00003170     History of Changes
Other Study ID Numbers: CDR0000065974, NCCTG-969256, NCI-P97-0127
Study First Received: November 1, 1999
Last Updated: September 29, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
stage 0 colon cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
stage 0 cervical cancer
stage III cervical cancer
recurrent cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IA cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014