NCT05223322

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

Active, Not Recruiting
NAAges 18+InterventionalSupportive care
Medical College of Wisconsin
~80 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Taking Charge during Treatment (TCT) Intervention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximal Exercise: Maximal oxygen consumption will be evaluated using cycle ergometry or treadmill to exhaustion as described in the Integrative Physiology Laboratory at each testing visit.
Measured over T1 (baseline), T2 (18-24 weeks), and T3 (12 months)
Breast Cancer
2 sites across 2 states
Illinois1
Wisconsin1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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
  • Maximal Exercise: Maximal oxygen consumption will be evaluated using cycle ergometry or treadmill to exhaustion as described in the Integrative Physiology Laboratory at each testing visit.T1 (baseline), T2 (18-24 weeks), and T3 (12 months)

    Investigators will use a graded protocol, starting at 50 watts followed by 30 watt increments every 2 minutes. Subjects will be connected to a breath-by-breath metabolic system (Cosmed, Italy) for measurement of VO2peak. A maximal effort will be defined as fulfillment of three of the following criteria: 1) A plateau in VO2 with an increase in work rate defined as an increase in VO2 of less than 50 ml/min; 2) A maximal HR within 10 beats of predicted maximal heart rate; 3) A respiratory exchange ratio of greater than 1.15; 4) No increase in heart rate with an increase in work rate (less than 3 beats); or 5) A rating of perceived exertion of 18 or greater on the Borg scale. These criteria are according to and consistent with the AHA exercise testing guidelines and performed regularly in Dr. Phillips' and Dr. Durand's laboratory groups59, 62-66.