Clinical Trials Directory

Trials / Completed

CompletedNCT04265547

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Columbia University · Academic / Other
Sex
Female
Age
10 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBreast Cancer Risk Reduction Household InterventionThis 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.

Timeline

Start date
2020-01-25
Primary completion
2020-11-21
Completion
2020-11-21
First posted
2020-02-11
Last updated
2025-09-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04265547. Inclusion in this directory is not an endorsement.