Exploring how cancer therapy affects inflammation and blood vessel function
DECODE Heartland: Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction
This study is testing if a special exercise program can help improve blood vessel health and reduce inflammation in Black and White women with early-stage breast cancer who are undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05223322 on ClinicalTrials.gov |
What this trial studies
This study investigates the off-target effects of cancer treatments on vascular health, particularly focusing on inflammation and endothelial dysfunction in patients with breast cancer. It utilizes advanced -omics technologies to analyze changes in gene and protein expression related to these effects. The intervention involves a program called Taking Charge during Treatment (TCT), which includes exercise and strength training, aimed at improving patient outcomes during chemotherapy. The study specifically targets Black/African American and non-Hispanic White women diagnosed with non-metastatic breast cancer receiving specific chemotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates are adult women assigned female at birth, diagnosed with invasive non-metastatic breast cancer, and receiving specific chemotherapy treatments.
Not a fit: Patients with metastatic disease or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of inflammation and vascular health in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While there is ongoing research into the effects of cancer therapies on vascular health, this specific approach combining exercise and -omics analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥ 18 years) assigned female sex at birth * Diagnosed with invasive non-metastatic breast cancer * Receiving neo-adjuvant CTx (or adjuvant CTx and undergoing breast conserving surgery) that includes anthracyclines (such as DOX) and/or targeted anti-Her2 therapy * Able to safely participate in moderate exercise and strength training based on MD approval * Willing to complete all study activities * Self-identifies as Black/African American or non-Hispanic White Exclusion Criteria: * Unintentional weight loss \> 10% in the past 6 months * Current pregnant and lactating patients. Must have completed lactation prior to study start * Metastatic disease * Diagnosed cardiovascular disease as evidenced by cardiomyopathy (reduced regional or global LV contractility), diastolic dysfunction grade 2 or above, symptomatic coronary - artery disease, ejection fraction below 50% * History of prior chemotherapy or targeted H2N Treatment received less than 3 years ago * Non-English speaking
Where this trial is running
Chicago, Illinois and 1 other locations
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
- Medical College of Wisconsin — Wauwatosa, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Melinda Stolley, PhD
- Email: mstolley@mcw.edu
- Phone: 414-955-7533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.