← Back to Search

Exercise for Breast Cancer Patients Undergoing Chemotherapy

N/A

Recruiting

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

Diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC, AC, TCHP, TCH with or without Pembrolizumab)

Age 18 years or over

Must not have

Acute myocarditis

Previous treatment with cardiotoxic chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if exercise can help reduce side effects of chemo, like heart problems and fatigue, and improve quality of life.

Who is the study for?

This trial is for adults over 18 with breast cancer (Stage I-III or minimal burden IV) who are about to start certain chemotherapies and can exercise. They must be cleared by a doctor, speak English, and not have had cardiotoxic chemo before. People with recent severe heart issues, uncontrolled high blood pressure, major organ diseases, pregnancy, or conditions that make exercising unsafe cannot join.

What is being tested?

The study tests if two types of exercise—moderate intensity walking and high-intensity interval training—can reduce the negative effects of chemotherapy on heart health, inflammation levels, and life quality in breast cancer patients.

What are the potential side effects?

While specific side effects aren't listed for the exercises being tested in this trial, typical risks might include muscle soreness or strain from physical activity. The safety of participants will be monitored throughout.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have breast cancer (early or minimal stage IV) and am on specific chemotherapy.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I have been diagnosed with acute myocarditis.

Select...

I have had chemotherapy that can harm the heart.

Select...

I cannot use a stationary bike due to health or orthopedic issues.

Select...

I have severe heart symptoms or irregular heartbeats.

Select...

I have had bleeding in the back of my eye.

Select...

I do not have major heart, kidney, liver, blood, or lung conditions that prevent me from exercising.

Select...

I have severe symptoms from a narrowed heart valve.

Select...

I sometimes do not take my medication as prescribed.

Select...

I have symptoms of poor blood flow in my limbs.

Select...

I have had a recent blood clot in my lung.

Select...

I have a severe eye condition that has not been treated.

Select...

I do not have uncontrolled diabetes or thyroid issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Subject Retention Percentage

Secondary study objectives

Blood pressure

Brachial Artery Endothelium-Dependent Flow-Mediated Dilation

Carotid-Femoral Pulse Wave Velocity

+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

Experimental Treatment

Group I: Moderate Intensity WalkingExperimental Treatment1 Intervention

Subjects allocated to moderate intensity walking will be given a gift card to purchase a paid of running shoes. A chest-based heart rate monitor and an activity tracker watch will be provided. Subjects will aim to achieve 150 minutes a week of moderate intensity walking. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity.

Group II: High Intensity Interval ExerciseExperimental Treatment1 Intervention

Subjects will receive a recumbent bike to be delivered and assembled to their home as well as a heart rate monitor and activity tracker. Subjects will undergo high intensity interval exercise 3 days a week, with the goal of achieving 85-90% of their heart rate max. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Intensity Interval Exercise

2021

N/A

~90

0 / 14Eligibility criteria met