NCT02370277

Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer

Changes in Intestinal Microbiota in Association With Chemotherapy Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ductal Breast Carcinoma In Situ
• Invasive Breast Carcinoma
• Stage I Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo collection of stool samples
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2014-12-16
• Primary completion: 2016-06-15
• Completion: 2018-08-22
• First posted: 2015-02-24
• Last updated: 2019-06-18

Locations

1 site across 1 country: United States