An observational study in Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma and Stage I Breast Cancer, sponsored by University of Southern California. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by University of Southern California · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 36 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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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.
Exclusion Criteria:
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.
Other: Cytology Specimen Collection Procedure · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
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.
Other: Cytology Specimen Collection Procedure · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
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
Other: Cytology Specimen Collection Procedure · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
Undergo collection of stool samples
Also known as: Cytologic Sampling
Correlative studies
Ancillary studies
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.
Time frame: Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course
Change in body composition based on dual-energy x-ray absorptiometry (DEXA)
Analyses of body composition measures will be based on fat mass, lean mass, and bone mineral content (BMC); each will be expressed in kilograms, on arms, legs, and trunk. Mixed effects regression models will be used to compare changes per week between pre-treatment assessment and 1 and 4 months after last chemotherapy. Additional analyses will use BMI group (normal, overweight, obese) for stratification and as a covariate in regression models. The relationship between body composition and gut microbiota before and after chemotherapy will be examined.
Time frame: Baseline to 4 months after last chemotherapy
Baseline estradiol and estrone levels
Changes in the microbiota composition, abundance and diversity will be correlated with baseline estradiol and estrone levels.
Time frame: Baseline
Change in estrogen levels
Correlation analyses of changes in the microbiota with changes in estrogen levels will be performed. Mixed effects regression analysis will be used to model systemic estrogen levels as a function of microbiota abundance and diversity, adjusting for cancer treatment, and baseline tumor and other individual characteristics.
Time frame: Baseline to up to 4 months after last chemotherapy
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Southern California