probiotic therapy in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy

Conditions: Cognitive/Functional Effects; Constipation, Impaction, and Bowel Obstruction; Diarrhea; Fatigue; Gastrointestinal Complications; Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific

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 studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.

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 the facit-d diarrhea subscale score in patients receiving concurrent chemotherapy and pelvic rt as adjuvant or primary treatment for malignancy. secondary * to determine whether vsl#3® can reduce chronic treatment-related bowel dysfunction following completion of therapy. * to examine whether vsl#3® appears to have an impact on disease-free survival. * to bank blood products for future studies. (exploratory) * to characterize changes in the fecal microbiota and examine for correlation with treatment assignment and symptom scores. (exploratory) outline: this is a randomized, double-blind, placebo-controlled study. patients are stratified according to site of primary tumor (rectum/anus vs other), history of anterior resection of the rectum (yes vs no), total planned cumulative dose (including boost of external-beam radiotherapy \[rt\] or brachytherapy) (4,500-5,350 cgy vs \> 5,350 cgy), and use of intensity-modulated rt \[imrt\] for pelvic rt (yes vs no). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive live freeze-dried lactic acid bacteria probiotic (vsl#3®) orally (po) 3 times a day during rt (5-8 weeks) and for 2 weeks after completion of rt. * arm ii: patients receive placebo po 3 times a day during rt (5-8 weeks) and for 2 weeks after completion of rt. patients self-report symptoms using the facit-d, pbfq, pro-ctcae, and uniscale/fatigue weekly during rt, for 2 weeks after completion of rt, and at 12 months following the completion of rt. blood and stool samples may be collected from some patients for correlative studies.

Eligibility criteria:
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

Keywords: diarrhea constipation, impaction, and bowel obstruction gastrointestinal complications fatigue psychosocial effects of cancer and its treatment cognitive/functional effects unspecified adult solid tumor, protocol specific