Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
|ClinicalTrials.gov Identifier: NCT01473290|
Recruitment Status : Withdrawn (The study was not activated.)
First Posted : November 17, 2011
Last Update Posted : July 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Dietary Supplement: live freeze-dried lactic acid bacteria probiotic Other: placebo||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
Experimental: 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.
Dietary Supplement: live freeze-dried lactic acid bacteria probiotic
Given orally (PO)
Placebo Comparator: Arm II
Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
- 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 [ Time Frame: Up to 12 months ]
- Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE [ Time Frame: Up to 12 months ]
- Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE [ Time Frame: Up to 12 months ]
- Disease-free survival [ Time Frame: Up to 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473290
|Principal Investigator:||Robert C. Miller, MD||Mayo Clinic|