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NCT02370277 · ClinicalTrials.gov registry record
Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer
A clinical trial, sponsored by University of Southern California.
- Completed
- Registry status
- 36
- Enrollment target
NCT02370277: Completed study, sponsored by University of Southern California.
NCT02370277 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02370277 has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
Study Summary
This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the types and quantity of bacterial composition in the stool of breast cancer patients treated with chemotherapy may help determine whether body weight and composition are associated with changes in the intestinal microbiota and allow doctors to plan better treatment to prevent weight gain and possibly disease recurrence.
Primary Outcome
Paired sample t-test will be used to determine whether there are significant changes in microbiota diversity (as measured by the number of taxonomic groups) between pre-treatment levels and 1 and 4 months after the final chemotherapy treatment. Mixed-model linear regression on repeated measures will be used to concurrently adjust for physical activity, dietary intakes, and other factors.
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- OTHER Cytology Specimen Collection Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-12-16 |
| Est. Completion | 2018-08-22 |
What the finished NCT02370277 record still lists
NCT02370277 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02370277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02370277 about?
NCT02370277 is a clinical study titled "Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer". This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated w...
What is the current status of trial NCT02370277?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2014-12-16. Estimated completion is 2018-08-22.
What interventions are being tested in trial NCT02370277?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Cytology Specimen Collection Procedure (OTHER).
Who is sponsoring clinical trial NCT02370277?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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