Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer
Changes in Intestinal Microbiota in Association With Chemotherapy Treatment
4 other identifiers
observational
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2014
CompletedFirst Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2018
CompletedJune 18, 2019
June 1, 2019
1.5 years
February 17, 2015
June 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in intestinal microbiota (composition, abundance, and diversity)
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.
Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course
Secondary Outcomes (3)
Change in body composition based on dual-energy x-ray absorptiometry (DEXA)
Baseline to 4 months after last chemotherapy
Baseline estradiol and estrone levels
Baseline
Change in estrogen levels
Baseline to up to 4 months after last chemotherapy
Study Arms (3)
Group A (stool collection after adjuvant chemotherapy)
Patients undergo collection of stool samples at baseline (before surgery), at 1 week before initiation of adjuvant chemotherapy (after surgery), and at 1 and 4 months after completion of adjuvant chemotherapy.
Group B (stool collection after adjuvant chemotherapy)
Patients undergo collection of stool samples at baseline (after surgery), at 1 week before initiation of adjuvant chemotherapy, and at 1 and 4 months after completion of adjuvant chemotherapy.
Group C (stool collection after neoadjuvant chemotherapy)
Patients undergo collection of stool samples at baseline, 1 month after completion of neoadjuvant chemotherapy (before surgery), and at 1 and 4 months after surgery
Interventions
Undergo collection of stool samples
Correlative studies
Ancillary studies
Eligibility Criteria
Patients with newly diagnosed breast cancer will be recruited from the Norris Comprehensive Cancer Center and the Los Angeles County + University of Southern California Medical Center.
You may qualify if:
- Newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer)
- A treatment group including surgery followed by standard treatment of adjuvant chemotherapy such as doxorubicin and cyclophosphamide followed by paclitaxel, docetaxel and cyclophosphamide, or a treatment group including neoadjuvant chemotherapy followed by surgery at the Norris or LAC+USC Medical Center
- Women of child-bearing potential agree to pregnancy test to confirm she is not pregnant
- Provide informed consent
You may not qualify if:
- Metastatic, recurrent, synchronous or metachronous breast cancer
- History of other cancers (other than non-melanoma skin cancer)
- History of autoimmune celiac or inflammatory bowel disease
- Past bariatric surgery
- Current or recent pregnancy or nursing (within past 12 months)
- Past treatment with chemotherapy
- Recent use (within past month) of more than 3 days of antibiotics use
- Current use of probiotic supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Biospecimen
Stool, blood, and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Wu
University of Southern California
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
February 24, 2015
Study Start
December 16, 2014
Primary Completion
June 15, 2016
Study Completion
August 22, 2018
Last Updated
June 18, 2019
Record last verified: 2019-06