Status:
RECRUITING
Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
University of Illinois at Chicago
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
Very little is understood about the off-target vascular mechanisms of anti-cancer drug toxicity and the impact of exercise on these changes. Much of what has been learned about molecular pathways regu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05223322
Start Date
March 1 2022
End Date
July 1 2026
Last Update
May 2 2025
Active Locations (2)
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1
University of Illinois Chicago
Chicago, Illinois, United States, 60607
2
Medical College of Wisconsin
Wauwatosa, Wisconsin, United States, 53226