Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Risk
• Intervention / Treatment: Behavioral: Breast Cancer Risk Reduction Household Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Mailman School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Arm; 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.	Behavioral: Breast Cancer Risk Reduction Household Intervention; 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.
NO_INTERVENTION: Control Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 6 months
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).	Baseline, 6 months
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).	Baseline, 6 months
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).	Baseline, 6 months
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 (%).	Baseline, 6 months
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.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI); University of Wisconsin, Madison; National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Mary Beth Terry, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2020
• Primary Completion (ANTICIPATED): January 25, 2021
• Study Completion (ANTICIPATED): January 25, 2021

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (ACTUAL): February 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Xenoestrogen; Household Intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AAAS2359; 5U01ES026127-04 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No