Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
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|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Recruitment Status : Withdrawn (The study was not activated.)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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473290
|Principal Investigator:||Robert C. Miller, MD||Mayo Clinic|