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

July 13, 2026 updated by: Melinda Stolley, Medical College of Wisconsin

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois Chicago
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Taking Charge during Treatment (TCT) Intervention
Taking Charge during Treatment (TCT) Intervention. TCT is a 16-20week intervention that promotes adoption of the ACSM exercise guidelines for cancer survivors during treatment, including regular moderate to vigorous physical activity (150 minutes per week of moderate activity or 75 minutes per week of vigorous activity) and a minimum of twice weekly resistance training (RT) minutes during CTx and after. Participants will receive "Take Charge" program binder, 2-4 x weekly text messaging, activity tracker and resistance bands.
Behavioral: Taking Charge during Treatment (TCT) Intervention
CT is a 16-20week intervention that promotes adoption of the ACSM exercise guidelines for cancer survivors during treatment, including regular moderate to vigorous physical activity (150 minutes per week of moderate activity or 75 minutes per week of vigorous activity) and a minimum of twice weekly resistance training (RT) minutes during CTx and after. Program components include (1) a binder of information, (2) weekly coaching, (3) 2-4x weekly text messaging and (4) exercise supplies. The TCT program is grounded in Social Cognitive Theory.
No Intervention: Control Group
To ensure scientific rigor allowing us to test causal pathways associated with exercise, women will be randomized to the TCT intervention or control group arm. The control group will not receive the TCT intervention The investigators experience teaches us that to increase the likelihood of retaining control group participants, the investigators must offer some resources. Thus, the investigators will provide the control group with a one-page summary of the American College of Sports Medicine exercise recommendations, and the "Take Charge" program binder at the completion of the study. Participants will also receive resistance bands and activity tracker at the end of the study. 95 The investigators will also send weekly text messages with supportive content not related to exercise or lifestyle (i.e., a riddle, "take a moment to smile today," a picture of a baby animal).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
T1 (baseline), T2 (18-24 weeks), and T3 (12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - General (FACT-B)
Time Frame: T1 (baseline), T2 (18-24 weeks), and T3 (12 months)
This survey measures physical, social, emotional, and functional wellbeing and wellness and symptoms associated with breast cancer and its treatments.
T1 (baseline), T2 (18-24 weeks), and T3 (12 months)
The Distress Thermometer
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
This is a simple tool to effectively screen for symptoms of distress.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Perceived Stress Scale
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
This survey is a class stress assessment to help understand how different situations affect feelings and perceived stress, asking about thoughts and feelings.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Hospital Anxiety and Depression Scale
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
This will measure anxiety and depression in a general medical population of patients.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
The Functional Assessment of Chronic Illness Therapy - Fatigue
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Participants will self-report fatigue and its impact upon daily activities and function.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
PROMIS - Social Support
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12 months)
This survey will assess how much social support each individual has in their personal network.
T1 (baseline), T2 (18-40 weeks), and T3 (12 months)
PROMIS - Pain Interference
Time Frame: T1 (baseline), T2 (18-24 weeks), and T3 (12-15 months)
This instrument will measure the self-reported consequences of pain on relevant aspects of a person's life.
T1 (baseline), T2 (18-24 weeks), and T3 (12-15 months)
Assess mitochondrial DNA damage
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Mitochondrial DNA damage will be assessed in isolated vessels from biopsies and total peripheral blood mononuclear blood cells (PBMCs) via a well-established PCR protocol. Similarly, a PCR based method is used to quantify levels of cell free mtDNA in plasma samples from study participants.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Cytokine analysis
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Investigators will utilize Isoplex platform via CodePlex Human Cytokine Storm Panel-8 to quantify a large array of inflammatory cytokines using minimal amounts (<30 ul) of plasma sample.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Gene Express Profiling
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (115 months)
Transcriptomic expression profiling of PBMC and endothelial cells will be performed utilizing existing infrastructure (Genomic Sciences and Precision Medicine Center at MCW). RNA sequencing will be performed Illumina on NovaSeq sequencer.
T1 (baseline), T2 (18-40 weeks), and T3 (115 months)
Endothelial function
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Microvascular function from gluteal and surgical fat biopsies will be used to test the direct effect of clinically used chemotherapy on peripheral microvascular function (as surrogate for coronary microvessels). Investigators propose to perform studies before, after the chemotherapy regimen, and at 12 months follow up. Study team evaluate microvascular dilator capacity, both endothelial and smooth muscle mediated, and quantify levels of vasodilators (NO and H2O2) via fluorescent probes.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Flow Mediated Dilation
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12 months)
Flow mediated dilation of the brachial artery (large conduit vessels) will be assessed using ultrasound in a noninvasive manner.
T1 (baseline), T2 (18-40 weeks), and T3 (12 months)
Cardiac function - Echocardiagram
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Echocardiograms: Aortic diameter, cardiac output, stroke volume, heart rate, end diastolic, and end systolic volume will be assessed at rest using two-dimensional echocardiography. With subjects in the left lateral position, measurements will be obtained using the two (Parasternal and Short Axis) and four-chamber view.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Cardiac function - Pulse Wave Velocity
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Pulse Wave Velocity: A non-invasive technique will be used to measure arterial stiffness (pulse wave velocity and central pressures). Briefly, investigators will record waveforms at the carotid and femoral arteries using tonometry and a partially inflated pressure cuff placed over the upper arm and thigh. The distance between sites will be determined using a tape measure.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Cognitive Function
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
PROMIS - Cognitive Function Short Form: This is a short six-item sub-set scale of the full PROMIS Cognitive Function item bank that assesses patient-perceived cognitive deficits
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DEXA Scan
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Body composition: DXA imaging is a 10 minute, noninvasive, technique that provides precise whole-body measurements of fat (total and visceral) and lean mass. Certified DXA technologists will perform and analyze whole body measures using the same machine for each participant at each time point. To ensure reliability and precision, machines are calibrated daily.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Height and Weight
Time Frame: T1 (baseline), T2 (18-24 weeks), and T3 (12-15 months)
Height and Weight: To calculate BMI, investigators will will assess height (baseline only) using a portable stadiometer and weight using a digital scale with participants wearing light clothes and no shoes. A 0.2 kg discrepancy in weight or a 0.5 cm discrepancy in height in the first two measurements, will result in a third measurement.
T1 (baseline), T2 (18-24 weeks), and T3 (12-15 months)
Accelerometry
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Accelerometry. Summary measures of PA levels will be derived from 7-day accelerometer wear data (% time sedentary, % time moderate to vigorous PA, counts per minute). Study team will adopt the common guideline of 10 hours or more of wear time necessary to define a valid day. Investigators will use the Troiano cut points (sedentary, light, moderate, vigorous).
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Physical Activity self report
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Godin Leisure Activity Index collects data on mild, moderate, and vigorous activity.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Pittsburgh Sleep Quality Index
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
This is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Sitting Time Questionnaire
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
The STQ is a 5-question self-report survey asking about amount of time spent sedentary.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Handgrip strength
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Measured with a Takei handgrip dynamometer. This test of LM function correlates with total body muscle strength73 and mortality74.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Sit to Stand
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Number of completed Sit to Stand repetitions performed in 30 secs using a chair with no arms with a height of approximately 43 cm75.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
6 Minute Walk Test
Time Frame: T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)
Total distance traveled in 6 mins is recorded and used to determine endurance.
T1 (baseline), T2 (18-40 weeks), and T3 (12-15 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00041443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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