Exercise Intervention for Breast Cancer-Related Inflammation (DECODE Trial)

Wauwatosa, WI

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (≥ 18 years) assigned female sex at birth

Diagnosed with invasive non-metastatic breast cancer

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (baseline), t2 (18-40 weeks), and t3 (12-15 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how cancer drugs impact the vascular system and whether or not exercise can help offset some of those changes.

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Who is the study for?

This trial is for adults assigned female at birth, diagnosed with non-metastatic breast cancer, receiving certain chemotherapy including anthracyclines or anti-Her2 therapy. Participants must be able to exercise safely and identify as Black/African American or non-Hispanic White. Excluded are those who don't speak English, have metastatic disease, are pregnant/lactating, have cardiovascular disease, prior similar treatments or significant recent weight loss.Check my eligibility

What is being tested?

The study tests the 'Taking Charge during Treatment' (TCT) Intervention aimed at understanding how cancer treatment-induced inflammation affects blood vessel function and if exercise can mitigate these effects. It uses advanced -omics technologies to predict microvascular dysfunction from chemotherapy.See study design

What are the potential side effects?

While specific side effects of the TCT Intervention aren't detailed here, potential risks may include typical reactions to moderate exercise and strength training such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult woman.

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I have been diagnosed with breast cancer that has not spread.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart disease with symptoms or an ejection fraction below 50%.

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I have had chemotherapy or targeted head and neck cancer treatment before.

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I have lost more than 10% of my weight without trying in the last 6 months.

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My cancer has spread to other parts of my body.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (baseline), t2 (18-40 weeks), and t3 (12-15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (baseline), t2 (18-40 weeks), and t3 (12-15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (baseline), t2 (18-40 weeks), and t3 (12-15 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Assess mitochondrial DNA damage

Cardiac function - Echocardiagram

Cardiac function - Pulse Wave Velocity

+12 more

Other study objectives

6 Minute Walk Test

Accelerometry

DEXA Scan

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Taking Charge during Treatment (TCT) InterventionActive Control1 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.

Group II: Control GroupActive Control1 Intervention

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).

0 / 6Eligibility criteria met