Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer
Completed
Conditions studied: Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02370277
- Run by
- University of Southern California
- People needed
- 36
- Starts
- 2014-12-16
- Expected to finish
- 2018-08-22
- Last updated by the study team
- 2019-06-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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