CompletedNot Applicable

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

United States32 participantsStarted 2020-01-25

Plain-language 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.

Who can participate

Age range10 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT04265547

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-21

View on ClinicalTrials.gov More Breast Cancer Risk trials

Plain-language summary

Who can participate

Age range10 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

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