Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Virginia
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- VO2 Peak
Study Overview
Brief Summary
The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, peripheral neuropathy, and quality of life.
Detailed Description
While survivorship for those diagnosed with epithelial ovarian cancer has continued to improve, the significant off target effects of adjuvant and neoadjuvant chemotherapy have become more prominent. These off-target effects include increased risk of cardiovascular disease, neuropathy, and decreased quality of life. Exercise initiated prior to chemotherapy induction and continued through treatment has promise in terms of preserving VO2peak and potentially mitigating the negative cardiovascular and neuropathic effects of chemotherapy. The goal of this study is to examine the effects of initiating exercise prior to any oncologic therapy and sustaining this exercise paradigm in newly diagnosed women with ovarian cancer who are undergoing initial surgery and chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the nature of the intervention (i.e. exercise training), participants and study team members cannot be blinded. However, outcomes assessment will be carried out in a blinded fashion.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or over
- •Presumed diagnosis of ovarian cancer and a planned chemotherapy regimen of a taxane and carboplatin with or without VEGF inhibition
- •Physician clearance for exercise training
Exclusion Criteria
- •Any patient unable/unwilling to cooperate with all study protocols
- •Cancer recurrence
- •Previous treatment with chemotherapy in the last 5-years
- •Medical/orthopedic co-morbidities that preclude exercise training
- •Significant heart, liver, kidney, blood, or respiratory disease precluding exercise participation
- •Peripheral vascular disease
- •Acute infectious disease or history of chronic infections
Arms & Interventions
Exercise
Patients in the exercise group will perform interval training 3 days per week.
Intervention: High intensity interval exercise (Behavioral)
Attention Control
Physical activity education and physical activity monitoring.
Intervention: Attention control (Behavioral)
Outcomes
Primary Outcomes
VO2 Peak
Time Frame: 22 weeks
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
Secondary Outcomes
- Brachial Artery Endothelium-Dependent Flow-Mediated Dilation(22 weeks)
- Diastolic Function(22 weeks)
- Ejection Fraction(22 weeks)
- Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire(22 weeks)
- Carotid-Femoral Pulse Wave Velocity(22 weeks)
- Blood pressure(22 weeks)
- Peripheral Neuropathy(22 weeks)
- Health Related Quality of Life as Measured by the FACT-O Questionnaire(22 weeks)
- Quality of Life as Assessed by the Short Form Health Survey (SF-36)(22 weeks)
- Global Longitudinal Strain(22 weeks)
Investigators
Siddartha Angadi
Assistant Professor
University of Virginia