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Changes in Intestinal Microbiota in Association with Chemotherapy Treatment

Description

This pilot study represents a first step to collect the critical data (stool sample collections, DEXA scan, blood and urine collection) that will allow us to systemically study the role of the gut microbiota in relation to outcome in breast cancer patients. Objective:The overall objective of this application is to investigate the short-term and long-term effects of chemotherapy on the gut microbiota of 45 newly diagnosed breast cancer patients undergoing chemotherapy.Study Population:Participants must be 18 years of age or older with newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer)Study Methodology:Longitudinal, observational, usual care.Study Arms:Plans A and B are for patients who will only get adjuvant chemotherapy but will not get neoadjuvant chemotherapy before their surgery.Plan C is for patients who will get neoadjuvant chemotherapy before their surgery but will not get adjuvant chemotherapy after surgery.Study Endpoints:The primary endpoints are changes in the gut microbiota. The secondary endpoints are baseline body composition (weight, BMI, waist and hip circumference, bone, fat and lean mass, and percent body fat) and estrogen levels as well as changes in body composition and estrogen levels.Follow-up:There will be 3 follow-up visits after baseline (SV1). These visits will take place in Dr. Wus private office suite which is located on the 4th floor of the Norris Topping Tower (Rm 4445).Statistics: With a sample size of 45 women, using a two-sided one-sample t-test at the alpha level of 0.05, we have 80% power to detect an average change in microbiota or body composition measure of 0.427 standard deviation.Analysis:All data collected (baseline questionnaires, clinical information, etc) at each of the three clinic visits will be checked and computerized on an ongoing basis. Prior to data entry, all forms will be reviewed for completeness and accuracy.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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

  • 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

Sites

Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.

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