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

Last updated: July 1, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Trial Not Available

Phase

3

Condition

Constipation

Colic

Ileus

Treatment

N/A

Clinical Study ID

NCT01473290
NCCTG-N10CB
CDR0000716291
NCI-2011-03636
  • Ages > 18
  • All Genders

Study 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.

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

Study Design

Study Start date:
Estimated Completion Date:

Study 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 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.