Ductal Breast Carcinoma In SituNCT02370277
Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer
An observational study of Ductal Breast Carcinoma In Situ and Invasive Breast Carcinoma, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer
- What is being tested?
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Questionnaire Administration
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2014to 22 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the transitory and longer lasting effects of chemotherapy on the gut microbiota.
SECONDARY OBJECTIVES:
- 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:
- 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
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of stool samples
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration | |
| 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration | |
| 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 Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to up to 4 months after last chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start16 Dec 2014
- Primary completion15 Jun 2016
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Wu, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370277
- Sponsor's protocol ID
- 1B-14-6
- Other IDs
- NCI-2014-02611, HS-14-00712, 1B-14-6, P30CA014089
- Status last verified
- Jun 2019
- First submitted
- 17 Feb 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Intestinal Microbiota in Association With Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT02370277
- Acronym / sponsor ID
- 1B-14-6
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine the transitory and longer lasting effects of chemotherapy on the gut microbiota.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (stool collection after adjuvant chemotherapy) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients 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 (stool collection after adjuvant chemotherapy) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients 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) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients undergo collection of stool samples at baseline, 1 month after completion of neoadjuvant chemotherapy (before surgery), and at 1 and 4 months after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of stool samples | Other | Group A (stool collection after adjuvant chemotherapy), Group B (stool collection after adjuvant chemotherapy), Group C (stool collection after neoadjuvant chemotherapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group A (stool collection after adjuvant chemotherapy), Group B (stool collection after adjuvant chemotherapy), Group C (stool collection after neoadjuvant chemotherapy) |
| Questionnaire AdministrationAncillary studies | Other | Group A (stool collection after adjuvant chemotherapy), Group B (stool collection after adjuvant chemotherapy), Group C (stool collection after neoadjuvant chemotherapy) |
Primary outcome
Change in intestinal microbiota (composition, abundance, and diversity)
Time frame: Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course
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.
3 secondary outcomes
Change in body composition based on dual-energy x-ray absorptiometry (DEXA)
Time frame: Baseline to 4 months after last chemotherapy
Baseline estradiol and estrone levels
Time frame: Baseline
Change in estrogen levels
Time frame: Baseline to up to 4 months after last chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Wu principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ductal Breast Carcinoma In Situ and Invasive Breast Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal microbiota (composition, abundance, and diversity) (time frame: Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.