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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01473290
Other study ID # NCCTG-N10CB
Secondary ID NCI-2011-03636CD
Status Withdrawn
Phase Phase 3
First received November 15, 2011
Last updated July 1, 2016

Study information

Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
live freeze-dried lactic acid bacteria probiotic
Given orally (PO)
Other:
placebo
Given PO

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE Up to 12 months No
Secondary Disease-free survival Up to 12 months No
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