Back to resultsFamily-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
Primary Purpose
Breast Cancer Risk
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Risk Reduction Household Intervention
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer Risk focused on measuring Breast Cancer, Xenoestrogen, Household Intervention
Eligibility Criteria
Inclusion Criteria:
- Participant of Columbia's Breast Cancer Research and the Environment (BCERP) Study that recruited from the Columbia Children's Center for Environmental Health (CCCEH) Mothers and Newborns cohort.
- Mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter).
- Mother was 18-35 years at time of daughter's delivery.
- Mother registered in the prenatal clinics by the 20th week of pregnancy.
- Mother free of diabetes, hypertension and reported HIV infection.
- Mother resided in northern Manhattan or the South Bronx neighborhoods of New York City for at least one year prior to pregnancy.
- Mother self-identified as African-American or Dominican.
- Only participants in the CCCEH birth cohort who answered in the affirmative to the question "I would like to be contacted about future studies" on the consent form of the Mothers and Newborns Study will be contacted to participate in this intervention.
Exclusion Criteria:
• None
Sites / Locations
- Columbia University Mailman School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Participants in the intervention arm will receive a 6-month supply of soap, lotion, deodorant, lip balm, a mop, cleaning cloths, and an air filter to take home with them. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion.
Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion. Control arm participants will be offered the chemical-free products, cleaning supplies, and air filter at this time.
Outcomes
Primary Outcome Measures
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of lipid (mg/cm^3) measured using an Optical Spectroscopy machine.
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of lipid (mg/cm^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of water (mg/cm^3) measured using an Optical Spectroscopy machine.
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of water (mg/cm^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of collagen (mg/cm^3) measured using an Optical Spectroscopy machine.
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of collagen (mg/cm^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of total hemoglobin (μM) measured using an Optical Spectroscopy machine.
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of total hemoglobin (μM).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of oxygenated hemoglobin (%).
Feasibility of measuring pre/post-intervention change in urinary metabolites of endocrine disrupting chemicals, including polycyclic aromatic hydrocarbons (PAH), phthalates, and parabens (all measured in μg/L units) .
Spot urines will be collected from mothers and daughters in each study arm at the pre-intervention and post-intervention clinic visits. Samples will be processed, aliquoted, and stored at -80°C within two hours of collection. Urinary concentrations of metabolites (μg/L) of PAH, phthalates and parabens will be measured in urine samples using commercially available ELISA kits. Blood samples will also be collected at pre- and post-intervention clinic visits using standard protocol, with the buffy coat of white blood cells, packed red blood cells, and plasma separated and stored in multiple aliquots at -80°C for future analyses. Each urine and blood sample will receive a unique barcode, blinding the lab technician to the study arms.
Secondary Outcome Measures
Full Information
NCT ID
NCT04265547
First Posted
February 6, 2020
Last Updated
February 10, 2020
Sponsor
Columbia University
Collaborators
National Institute of Environmental Health Sciences (NIEHS), National Cancer Institute (NCI), University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04265547
Brief Title
Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
Official Title
Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2020 (Actual)
Primary Completion Date
January 25, 2021 (Anticipated)
Study Completion Date
January 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Environmental Health Sciences (NIEHS), National Cancer Institute (NCI), University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study is being conducted to find out whether changes in household and personal behavior aimed at reducing exposure to environmental chemicals in dust (increased house dust removal efforts/cleaning and hand washing) and consumer products (increased us of personal care and beauty products that are free of chemicals including phthalates, parabens, and phenols) results in lower exposure to environmental chemicals including polycyclic aromatic hydrocarbons (PAHs) and endocrine disrupting chemicals including phthalates, parabens and phenols. These chemicals may have harmful health effects, as they can interfere with normal functions of the body. This study will also assess changes in breast tissue composition to understand the role of environmental exposures in breast cancer risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Risk
Keywords
Breast Cancer, Xenoestrogen, Household Intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Participants in the intervention arm will receive a 6-month supply of soap, lotion, deodorant, lip balm, a mop, cleaning cloths, and an air filter to take home with them. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion. Control arm participants will be offered the chemical-free products, cleaning supplies, and air filter at this time.
Intervention Type
Behavioral
Intervention Name(s)
Breast Cancer Risk Reduction Household Intervention
Intervention Description
This study will focus the intervention on ways at the individual level to reduce sources of Polycyclic Aromatic Hydrocarbons (through cooking methods, exposure to cigarette smoking, indoor air filters) and also individual ways to reduce sources of other Endocrine Disrupting Chemicals. Mother-daughter pairs will partake in an educational session at the baseline visit, covering topics on reading labels, cleaning habits, and cooking methods for reducing exposures. Participants will also be introduced to free resources for consumer product safety information. The intervention arm will receive a 6-month supply of soap, lotion, deodorant, lip balm, a mop, cleaning cloths, and an air filter to take home with them. Pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy measurement, and questionnaire completion. The control arm will be offered the intervention products at this time.
Primary Outcome Measure Information:
Title
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of lipid (mg/cm^3) measured using an Optical Spectroscopy machine.
Description
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of lipid (mg/cm^3).
Time Frame
Baseline, 6 months
Title
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of water (mg/cm^3) measured using an Optical Spectroscopy machine.
Description
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of water (mg/cm^3).
Time Frame
Baseline, 6 months
Title
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of collagen (mg/cm^3) measured using an Optical Spectroscopy machine.
Description
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of collagen (mg/cm^3).
Time Frame
Baseline, 6 months
Title
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of total hemoglobin (μM) measured using an Optical Spectroscopy machine.
Description
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of total hemoglobin (μM).
Time Frame
Baseline, 6 months
Title
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
Description
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of oxygenated hemoglobin (%).
Time Frame
Baseline, 6 months
Title
Feasibility of measuring pre/post-intervention change in urinary metabolites of endocrine disrupting chemicals, including polycyclic aromatic hydrocarbons (PAH), phthalates, and parabens (all measured in μg/L units) .
Description
Spot urines will be collected from mothers and daughters in each study arm at the pre-intervention and post-intervention clinic visits. Samples will be processed, aliquoted, and stored at -80°C within two hours of collection. Urinary concentrations of metabolites (μg/L) of PAH, phthalates and parabens will be measured in urine samples using commercially available ELISA kits. Blood samples will also be collected at pre- and post-intervention clinic visits using standard protocol, with the buffy coat of white blood cells, packed red blood cells, and plasma separated and stored in multiple aliquots at -80°C for future analyses. Each urine and blood sample will receive a unique barcode, blinding the lab technician to the study arms.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant of Columbia's Breast Cancer Research and the Environment (BCERP) Study that recruited from the Columbia Children's Center for Environmental Health (CCCEH) Mothers and Newborns cohort.
Mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter).
Mother was 18-35 years at time of daughter's delivery.
Mother registered in the prenatal clinics by the 20th week of pregnancy.
Mother free of diabetes, hypertension and reported HIV infection.
Mother resided in northern Manhattan or the South Bronx neighborhoods of New York City for at least one year prior to pregnancy.
Mother self-identified as African-American or Dominican.
Only participants in the CCCEH birth cohort who answered in the affirmative to the question "I would like to be contacted about future studies" on the consent form of the Mothers and Newborns Study will be contacted to participate in this intervention.
Exclusion Criteria:
• None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Terry, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Mailman School of Public Health
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
We'll reach out to this number within 24 hrs