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Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic 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
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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Timothy F. Kozelsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Cancer
  • 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
  • stage II Wilms tumor
  • stage III Wilms tumor
  • stage IV Wilms tumor
  • stage V Wilms tumor
  • stage 0 vulvar cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IVB vulvar cancer
  • recurrent vulvar cancer
  • stage 0 vaginal cancer
  • stage I vaginal cancer
  • stage II vaginal cancer
  • stage III vaginal cancer
  • stage IVA vaginal cancer
  • stage IVB vaginal cancer
  • recurrent vaginal cancer
  • stage I penile cancer
  • stage II penile cancer
  • stage III penile cancer
  • stage IV penile cancer
  • recurrent penile cancer
  • stage 0 endometrial carcinoma
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • unresectable gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • stage I malignant testicular germ cell tumor
  • stage II malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • recurrent malignant testicular germ cell tumor
  • stage IV adult soft tissue sarcoma
  • ovarian stromal cancer
  • recurrent urethral cancer
  • distal urethral cancer
  • proximal urethral cancer
  • urethral cancer associated with invasive bladder cancer
  • stage I ovarian germ cell tumor
  • stage II ovarian germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • localized transitional cell cancer of the renal pelvis and ureter
  • extragonadal germ cell tumor
  • low risk metastatic gestational trophoblastic tumor
  • fallopian tube cancer
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • placental-site gestational trophoblastic tumor
  • radiation toxicity
  • diarrhea
  • stage II adult soft tissue sarcoma
  • stage I adult soft tissue sarcoma
  • stage IV pancreatic cancer
  • Diarrhea



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080