Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-25 @ 3:57 PM
Study NCT ID:
NCT07137468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Everyday Exposures: How Chemicals and Weight Impact Breast Cancer Risk
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Excessive Weight, Breast Cancer, and Endocrine Disrupting Chemicals (EDCs): Findings From Active Living After Cancer (ALAC) With Environmental Vitality
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn about breast cancer survivor's knowledge of and interest in learning about environmental exposures related to personal care products. Researchers also want to learn if there is a link between excessive weight and chemicals that may affect hormones.
Detailed Description:
Primary Objectives:
Excessive body weight, endocrine disrupting chemicals (EDCs), and breast cancer are interconnected through disruptions in hormone balance, with notable disparities in risk and outcomes for under-resourced communities. Excessive weight is a risk factor for breast cancer particularly in postmenopausal individuals, primarily due to increased estrogen production from adipose tissue.
EDCs, such as parabens, bisphenols, and phthalates, have been implicated in both excessive weight and breast cancer, particularly in hormone-sensitive breast cancer subtypes. These non-persistent chemicals are commonly found in personal care products, such as cosmetics and hair care items. Parabens have been shown to promote pro-tumorigenic effects in luminal breast cancer cells, raising concerns about their role in breast cancer incidence. Research has also highlighted that African American individuals face higher exposure to EDCs, especially through hair and other personal care products marketed to people of color, which may contribute to disparities in breast cancer risk.
The relationship between weight and breast cancer is complex with differences in body mass index influencing risk. Under-resourced groups are more likely to be diagnosed with aggressive late-stage breast cancer, a risk further exacerbated by high body weight. Moreover, disparities in healthcare access, economic and social standing, and exposure to EDCs, also known as non-medical drivers of health (NMDOH), may compound breast cancer mortality rates in these communities.
The overall goal of this proposal is to engage participants from the ALAC program and determine their knowledge and interest in environmental exposure education focused on personal care products. The information gained from our efforts will support the development of the Active Living After Cancer with Environmental Vitality (ALAC-ENV) intervention to improve QOL.
Additionally, we will determine the association between prevalent EDCs and excessive weight for breast cancer survivors. To achieve this goal, we will pursue the following specific aims:
Specific Aim 1: Determine breast cancer survivors' environmental exposure knowledge. Participants (n=30; pilot-tested group (n=6-8)) will participate in focus group interviews to assess their interest and understanding of environmental exposures with an emphasis on personal care products. Participants in the pilot-testing group will assist with potential modifications regarding the focus group guide. Participants in the pilot-testing group will be recognized as "Focus Group 1" participants and will complete all protocol procedures.
Specific Aim 2: Determine the relationship between exposures to prevalent EDCs and BMI. A cross-sectional design to examine associations between BMI and measurements of non-persistent EDCs in urine samples of cancer survivors.
Emerging evidence on the disproportionate exposure to carcinogenic chemicals and its role in cancer-related disparities underscores the need for this study. The limited understanding of the relationship between EDCs and weight-related cancers further highlights the importance of exploring pathways to mitigate health risks in under-resourced communities. Findings from this study will inform an R-level grant to develop a randomized trial testing the efficacy of an adapted ALAC-ENV curriculum for dissemination and implementation in community settings. Additionally, we will seek foundation grant support for a cross-sectional study examining the association between body mass index, EDC exposure, and cancer in Acres Homes within the context of NMDOH.
Excessive body weight, endocrine disrupting chemicals (EDCs), and breast cancer are interconnected through disruptions in hormone balance, with notable disparities in risk and outcomes for under-resourced communities. Excessive weight is a risk factor for breast cancer particularly in postmenopausal individuals, primarily due to increased estrogen production from adipose tissue.
EDCs, such as parabens, bisphenols, and phthalates, have been implicated in both excessive weight and breast cancer, particularly in hormone-sensitive breast cancer subtypes. These non-persistent chemicals are commonly found in personal care products, such as cosmetics and hair care items. Parabens have been shown to promote pro-tumorigenic effects in luminal breast cancer cells, raising concerns about their role in breast cancer incidence. Research has also highlighted that African American individuals face higher exposure to EDCs, especially through hair and other personal care products marketed to people of color, which may contribute to disparities in breast cancer risk.
The relationship between weight and breast cancer is complex with differences in body mass index influencing risk. Under-resourced groups are more likely to be diagnosed with aggressive late-stage breast cancer, a risk further exacerbated by high body weight. Moreover, disparities in healthcare access, economic and social standing, and exposure to EDCs, also known as non-medical drivers of health (NMDOH), may compound breast cancer mortality rates in these communities.
The overall goal of this proposal is to engage participants from the ALAC program and determine their knowledge and interest in environmental exposure education focused on personal care products. The information gained from our efforts will support the development of the Active Living After Cancer with Environmental Vitality (ALAC-ENV) intervention to improve QOL.
Additionally, we will determine the association between prevalent EDCs and excessive weight for breast cancer survivors. To achieve this goal, we will pursue the following specific aims:
Specific Aim 1: Determine breast cancer survivors' environmental exposure knowledge. Participants (n=30; pilot-tested group (n=6-8)) will participate in focus group interviews to assess their interest and understanding of environmental exposures with an emphasis on personal care products. Participants in the pilot-testing group will assist with potential modifications regarding the focus group guide. Participants in the pilot-testing group will be recognized as "Focus Group 1" participants and will complete all protocol procedures.
Specific Aim 2: Determine the relationship between exposures to prevalent EDCs and BMI. A cross-sectional design to examine associations between BMI and measurements of non-persistent EDCs in urine samples of cancer survivors.
Emerging evidence on the disproportionate exposure to carcinogenic chemicals and its role in cancer-related disparities underscores the need for this study. The limited understanding of the relationship between EDCs and weight-related cancers further highlights the importance of exploring pathways to mitigate health risks in under-resourced communities. Findings from this study will inform an R-level grant to develop a randomized trial testing the efficacy of an adapted ALAC-ENV curriculum for dissemination and implementation in community settings. Additionally, we will seek foundation grant support for a cross-sectional study examining the association between body mass index, EDC exposure, and cancer in Acres Homes within the context of NMDOH.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06013 | OTHER | NCI-CTRP Clinical Trials Registry | View |