Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003170
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE September 6, 2004
Last Update Posted Date July 14, 2016
Study Start Date  ICMJE February 1998
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • reduction of acute treatment related to diarrhea [ Time Frame: Up to 2 years post-radiation treatment ]
  • reduction of chronic treatment related to enteropathy [ Time Frame: Up to 2 years post-radiation treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer
Official Title  ICMJE Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Dietary Supplement: glutamine
  • Other: placebo
Study Arms  ICMJE
  • Experimental: glutamine
    Beginning the first or second day of radiotherapy, patients receive oral glutamine 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.
    Intervention: Dietary Supplement: glutamine
  • Placebo Comparator: placebo
    Beginning the first or second day of radiotherapy, patients receive 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.
    Intervention: Other: placebo
Publications * Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol. 2003 May 1;21(9):1669-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
129
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003170
Other Study ID Numbers  ICMJE NCCTG-969256
CDR0000065974 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-P97-0127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Timothy F. Kozelsky, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP