Breast Cancer Clinical Trial

Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Summary

The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.

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Full Description

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy

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Eligibility Criteria

3.1 Inclusion Criteria

Women with a breast cancer diagnosis (Stage I-IIIC)
Sedentary (< 75 min/wk of moderate intensity exercise over the past month)
No previous history of anthracycline based chemotherapy
Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
Absence of contraindications for neoadjuvant chemotherapy
Scheduled to receive neoadjuvant chemotherapy
Primary attending oncologist approval

3.2 Exclusion Criteria

Absolute contraindications for exercise stress testing

acute myocardial infarction (3-5 days)
unstable angina
uncontrolled arrhythmias causing symptoms or hemodynamic compromise
syncope
acute endocarditis
acute myocarditis or pericarditis
uncontrolled heart failure
acute pulmonary embolus or pulmonary infarction
thrombosis of lower extremities
suspected dissecting aneurysm
uncontrolled asthma
pulmonary edema
room air desaturation at rest ≤85%
respiratory failure
acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
mental impairment leading to inability to cooperate
decisional impairment
Non-English speaking
Women only diagnosed with ductal carcinoma in situ
Women diagnosed with stage 4 metastatic breast cancer
Pregnant women
Men
Children

Study is for people with:

Breast Cancer

Estimated Enrollment:

19

Study ID:

NCT03280836

Recruitment Status:

Completed

Sponsor:

Milton S. Hershey Medical Center

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There are 2 Locations for this study

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Penn State Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

19

Study ID:

NCT03280836

Recruitment Status:

Completed

Sponsor:


Milton S. Hershey Medical Center

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