Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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