Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
FEMALE
NCT05223322

Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Led by Medical College of Wisconsin · Updated on 2025-05-02

80

Participants Needed

2

Research Sites

226 weeks

Total Duration

On this page

Sponsors

M

Medical College of Wisconsin

Lead Sponsor

U

University of Illinois at Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 regulating vascular endothelial function has been established by logical expansion of knowledge obtained through experimental studies (e.g., discovery of endothelium-derived relaxing factor/nitric oxide). Within the last 10 years technological advancements of -omics approaches, such as RNA-sequencing and shotgun proteomics, have dramatically reduced the cost and technical challenge of accessing these tools for discovery-based research. Investigators are now able to obtain unbiased datasets showing changes in transcript or protein expression within complex samples. With cost and accessibility of sequencing is no longer being substantial bottleneck, one of major challenges researchers now face is determining how to meaningfully interpret profiles from large datasets. The extensive characterization of molecular pathways impacting inflammatory responses, endothelial function and angiogenesis, the pathway and network analysis tools will be an asset for identification molecular pathways relevant to alterations in microvascular endothelial function. The investigators preliminary studies on only a small number of samples highlights this potential of the proposed approach to lead to identify personalized medicine-based profiles that will predict patients are likely to develop microvascular endothelial dysfunction from CTx.

CONDITIONS

Official Title

Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Who Can Participate

Age: 18Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥ 18 years) assigned female sex at birth
  • Diagnosed with invasive non-metastatic breast cancer
  • Receiving neo-adjuvant chemotherapy or adjuvant chemotherapy with breast conserving surgery including anthracyclines or targeted anti-Her2 therapy
  • Medically approved to safely participate in moderate exercise and strength training
  • Willing to complete all study activities
  • Self-identifies as Black/African American or non-Hispanic White
Not Eligible

You will not qualify if you...

  • Unintentional weight loss > 10% in the past 6 months
  • Currently pregnant or lactating (must have completed lactation before study start)
  • Metastatic disease
  • Diagnosed cardiovascular disease including cardiomyopathy, grade 2 or higher diastolic dysfunction, symptomatic coronary artery disease, or ejection fraction below 50%
  • Received prior chemotherapy or targeted Her2 treatment within the last 3 years
  • Non-English speaking

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Illinois Chicago

Chicago, Illinois, United States, 60607

Actively Recruiting

2

Medical College of Wisconsin

Wauwatosa, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Melinda Stolley, PhD

CONTACT

C

Courtney Jankowski, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction | DecenTrialz