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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000065974 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-P97-0127 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glutamine | Experimental | 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. |
|
| placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glutamine | Dietary Supplement |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of acute treatment related to diarrhea | Up to 2 years post-radiation treatment | |
| reduction of chronic treatment related to enteropathy | Up to 2 years post-radiation treatment |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Timothy F. Kozelsky, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| CCOP - Illinois Oncology Research Association |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12721240 | Result | 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. doi: 10.1200/JCO.2003.05.060. |
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|
| Peoria |
| Illinois |
| 61602 |
| United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 10309-1016 | United States |
| Siouxland Hematology-Oncology | Sioux City | Iowa | 51101-1733 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CentraCare Clinic | Saint Cloud | Minnesota | 56303 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| Quain & Ramstad Clinic, P.C. | Bismarck | North Dakota | 58501 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57105-1080 | United States |
| Saskatchewan Cancer Agency | Regina | Saskatchewan | S4S 6X3 | Canada |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D021542 | Amino Acids, Neutral |
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