Breast Cancer Clinical Trial

Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.

Summary

To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.

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Full Description

Given that this is the first study to explore the potential effects of exercise training on exercise capacity, tumor vascularity and response in women undergoing neoadjuvant chemotherapy for operable breast cancer, prior to the initiation of the full investigation, we will conduct a small vanguard study to ensure we can achieve acceptable exercise adherence rates in the absence of dose-limiting toxicities (DLTs). Specifically, three operable breast cancer patients will be recruited and enrolled as described below and perform exercise training for a minimum of six weeks. If acceptable exercise rates are observed in the absence of severe DLTs during this time, we will proceed with the full investigation (recruitment of additional 20 patients) (see Figure 2). Using a prospective, randomized design, potential participants will be identified and screened for eligibility by an assigned Breast Protocol Nurse (TBD) via medical record review of patients scheduled for their primary neoadjuvant chemotherapy consultation at DCCC

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Eligibility Criteria

Inclusion Criteria:

Histologically confirmed operable primary breast cancer
Age 18 or older
Karnofsky performance status greater than 70
No previous malignancy
Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%)
No hormonal replacement therapy use within the past month
Not pregnant
Ability to read and understand English
Signed written informed consent prior to beginning protocol specific procedures
Willing to travel to DUMC to exercise three times per week
Primary treating oncologist approval

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

23

Study ID:

NCT00405678

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

23

Study ID:

NCT00405678

Recruitment Status:

Completed

Sponsor:


Duke University

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