Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
- Conditions
- DiarrheaGastrointestinal ComplicationsConstipation, Impaction, and Bowel ObstructionCognitive/Functional EffectsFatigueUnspecified Adult Solid Tumor, Protocol SpecificPsychosocial Effects of Cancer and Its Treatment
- Interventions
- Dietary Supplement: live freeze-dried lactic acid bacteria probioticOther: placebo
- Registration Number
- NCT01473290
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I live freeze-dried lactic acid bacteria probiotic 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 placebo Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
- Primary Outcome Measures
Name Time Method 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 Up to 12 months
- Secondary Outcome Measures
Name Time Method Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE Up to 12 months Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE Up to 12 months Disease-free survival Up to 12 months