Clinical trial NCT04265547: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Risk
Keywords: Breast Cancer
Xenoestrogen
Household Intervention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: National Cancer Institute (NCI)
name: University of Wisconsin, Madison
First posted: 2020-02-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of lipid (mg/cm^3) measured using an Optical Spectroscopy machine.
timeFrame: Baseline, 6 months
measure: Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of water (mg/cm^3) measured using an Optical Spectroscopy machine.
timeFrame: Baseline, 6 months
measure: Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of collagen (mg/cm^3) measured using an Optical Spectroscopy machine.
timeFrame: Baseline, 6 months
measure: Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of total hemoglobin (μM) measured using an Optical Spectroscopy machine.
timeFrame: Baseline, 6 months
measure: Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
timeFrame: Baseline, 6 months
measure: 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) .
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Mailman School of Public Health
state: New York
Study officials:
affiliation: Columbia University
name: Mary Beth Terry, PhD
role: PRINCIPAL_INVESTIGATOR
References: