Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy

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