Exercise Preconditioning in Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Behavioral: High intensity interval exerciseBehavioral: Attention control
- Registration Number
- NCT05029154
- Lead Sponsor
- University of Virginia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise High intensity interval exercise Patients in the exercise group will perform interval training 3 days per week. Attention Control Attention control Physical activity education and physical activity monitoring.
- Primary Outcome Measures
Name Time Method VO2 Peak 22 weeks Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
- Secondary Outcome Measures
Name Time Method Brachial Artery Endothelium-Dependent Flow-Mediated Dilation 22 weeks Changes in endothelial function as measured by brachial artery endothelium-dependent flow-mediated dilation (%) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Diastolic Function 22 weeks E' and A' (cm/s) will be used to calculate the E'/A' ratio to assess for diastolic dysfunction and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy
Ejection Fraction 22 weeks Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy
Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire 22 weeks The functional assessment of cancer therapy/gynecologic oncology group- neurotoxicity (FACT-GOG-NTX) questionnaire is used to assess symptoms of peripheral neuropathy. This 38 item questionnaire utilizes the same questions as the FACT questionnaire with 11 questions specific to peripheral neuropathy. A 5 point Likert scale is used for each question and subscores are added together with high scores indicating better quality of life
Carotid-Femoral Pulse Wave Velocity 22 weeks Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Blood pressure 22 weeks Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Peripheral Neuropathy 22 weeks A Neuropen will be used to assess for peripheral neuropathy via changes in perception to pressure prior to chemotherapy, at cycle 4, and after cycle 6.
Health Related Quality of Life as Measured by the FACT-O Questionnaire 22 weeks The functional assessment of cancer therapy- ovarian cancer(FACT-O) questionnaire is used to assess health-related quality of life specific to cancer and includes a subscale for ovarian cancer. This 38 item questionnaire utilizes the same questions as the FACT questionnaire with 12 questions specific to ovarian cancer. A 5 point Likert scale is used for each question and subscores are added together with high scores indicating better quality of life
Quality of Life as Assessed by the Short Form Health Survey (SF-36) 22 weeks The Short Form Health survey is a 36 item questionnaire that is used to measure general health and quality of life. Responses in each section are scored on a scale of 0-100 (with 100 indicating good health) and averaged together for each subscale score.
Global Longitudinal Strain 22 weeks Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy
Trial Locations
- Locations (1)
University of Virginia University Hospital
🇺🇸Charlottesville, Virginia, United States