To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Subjects receiving chemo with exercise training
Subjects receiving chemo only
Duke University Medical Center
Durham, North Carolina, United States
Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test
Time frame: 3 months
Adherence to fitness program
Time frame: 3 months
Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale.
Time frame: 3 months
Determine and define feasibility for an adequately powered Phase III study.
Time frame: 3 months
Determine effects of exercise training on tumor vascularity, systemic response and tumor response.
Time frame: 3 months
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