Primary Outcome Measures:
- Determine effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients before, mid-way through and after completion of neoadjuvant chemotherapy.
Secondary Outcome Measures:
- Determine the following:
- Effects of exercise on tumor vascularity, systemic response and tumor response
- Patients' adherence levels to such a program during neoadjuvant chemotherapy
- Effects of exercise on quality of life.
- Patient eligibility and recruitment.
- Primary endpoint for sample size calculations for a future adequately powered phase III RCT
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
Purpose
