Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01473290

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

A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in the Prevention of Acute Enteritis in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy

Status
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTlive freeze-dried lactic acid bacteria probioticGiven orally (PO)
OTHERplaceboGiven PO

Timeline

First posted
2011-11-17
Last updated
2016-07-06

Source: ClinicalTrials.gov record NCT01473290. Inclusion in this directory is not an endorsement.