Stage IIIA Breast Cancer Clinical Trial
Official title:
Changes in Intestinal Microbiota in Association With Chemotherapy Treatment
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 OBJECTIVES:
I. To examine the transitory and longer lasting effects of chemotherapy on the gut
microbiota.
SECONDARY OBJECTIVES:
I. To examine the relationship between body composition and gut microbiota before and after
chemotherapy.
II. To examine the relationship between blood estrogen levels and gut microbiota before and
after chemotherapy.
TERTIARY OBJECTIVES:
I. To examine the relationship between changes in the gut microbiota by pre-treatment body
mass index (BMI) (normal - BMI < 25 kg/m^2, overweight - BMI >= 25-< 30 kg/m^2, and obese-
BMI >= 30 kg/m^2) and by changes in body composition in relation to chemotherapy.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP A: 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: 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: 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.
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