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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02611 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HS-14-00712 | |||
| 1B-14-6 | Other Identifier | USC Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (stool collection after adjuvant chemotherapy) | 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. |
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| Group B (stool collection after adjuvant chemotherapy) | 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 (stool collection after neoadjuvant chemotherapy) | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo collection of stool samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Wu | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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Stool, blood, and urine
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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. | 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. | Baseline to up to 4 months after last chemotherapy |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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