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
- 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.
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT
Robert C. Miller, MD