Status:
WITHDRAWN
Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cognitive/Functional Effects
Constipation, Impaction, and Bowel Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy. PURPOSE: This randomized phase III trial is studyin...
Detailed Description
OBJECTIVES: Primary * To determine whether live freeze-dried lactic acid bacteria probiotic (VSL#3®) is effective in reducing the acute treatment-related bowel function disturbances, as measured by ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam radiotherapy (RT) to the pelvis to a minimum dose of 4,500 cGy with the following parameters:
- The pelvis must be encompassed by the planned RT fields
- The superior border may not lie inferior to the most inferior aspect of the sacroiliac joints
- Portions of the rectum may have special blocking, depending upon disease site
- The total prescription dose must lie between 4,500-5,350 cGy (inclusive)
- A boost to primary tumor or tumor bed may be planned
- Planned treatment is to be given 4-5 times per week on a one- treatment-per-day basis
- The daily prescribed dose must lie between 170-210 cGy (inclusive) per day
- No planned split-course RT
- No proton RT
- Will receive concurrent administration of chemotherapy (fluorouracil, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin C) during pelvic RT
- No current or prior metastases beyond regional lymph nodes
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) of 0, 1, or 2
- Life expectancy ≥ 6 months
- Able to complete questionnaire(s) by themselves or with assistance
- Not pregnant or nursing
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Fertile patients must use effective contraception
- Hemoglobin \> 10.0 g/dL
- White blood cells (WBC) \> 3,500/mm³
- Absolute neutrophil count (ANC) \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
- No known allergy to a probiotic preparation
- No history of inflammatory bowel disease
- No ≥ grade 3 diarrhea, ≥ grade 3 rectal bleeding, abdominal cramping, or incontinence of stool ≤ 7 days prior to registration
- No medical condition that may interfere with ability to receive protocol treatment
- No history of gastrointestinal or genitourinary obstruction or porphyria
- No history of irritable bowel syndrome (IBS)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
- No planned use of leucovorin
- No prior pelvic RT
- No use of probiotics ≤ 2 weeks prior to registration
- No use of antibiotics ≤ 3 days prior to registration
- No planned continuous antibiotic treatment during RT
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01473290
Last Update
July 6 2016
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