Back to resultsExercise Preconditioning in Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity interval exercise
Attention control
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Cancer focused on measuring Cardiotoxicity, Ovarian Cancer, Exercise Training, Chemotherapy, Cardiovascular toxicity ovarian cancer chemotherapy
Eligibility Criteria
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
Sites / Locations
- University of Virginia University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Attention Control
Arm Description
Patients in the exercise group will perform interval training 3 days per week.
Physical activity education and physical activity monitoring.
Outcomes
Primary Outcome Measures
VO2 Peak
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
Secondary Outcome Measures
Global Longitudinal Strain
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
Ejection Fraction
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
Diastolic Function
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
Brachial Artery Endothelium-Dependent Flow-Mediated Dilation
Changes in endothelial function as measured by brachial artery endothelium-dependent flow-mediated dilation (%) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Carotid-Femoral Pulse Wave Velocity
Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Blood pressure
Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Peripheral Neuropathy
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.
Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire
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
Health Related Quality of Life as Measured by the FACT-O Questionnaire
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05029154
Brief Title
Exercise Preconditioning in Ovarian Cancer
Official Title
Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Cardiotoxicity, Ovarian Cancer, Exercise Training, Chemotherapy, Cardiovascular toxicity ovarian cancer chemotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm randomized control trial
Masking
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.
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Patients in the exercise group will perform interval training 3 days per week.
Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
Physical activity education and physical activity monitoring.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval exercise
Intervention Description
Patients in the exercise group will perform interval training (HIIT) 3 days per week, with each session consisting of four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Patients will undergo 2 initial training sessions at the exercise physiology core lab. All exercise will consist of stationary cycling to avoid discomfort associated with abdominal surgery as well as stress to the incision and help reduce fall risk. Study investigators will check in weekly with participants and remotely track exercise data and compliance via the Fitbit app.
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Intervention Description
Patients in the control group (physical activity education and physical activity monitoring) will receive counseling regarding the benefits of physical activity during chemotherapy treatment. During the intervention, participants will receive a weekly phone call to discuss their physical activity and remind them to engage in physical activity. Patients will be given a goal of working up to 30 minutes of exercise daily. Subjects will be urged to increase daily step counts by 250-500 steps/day. Physical activity will be objectively assessed and made available to the participant using a Fitbit.
Primary Outcome Measure Information:
Title
VO2 Peak
Description
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Global Longitudinal Strain
Description
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
Time Frame
22 weeks
Title
Ejection Fraction
Description
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
Time Frame
22 weeks
Title
Diastolic Function
Description
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
Time Frame
22 weeks
Title
Brachial Artery Endothelium-Dependent Flow-Mediated Dilation
Description
Changes in endothelial function as measured by brachial artery endothelium-dependent flow-mediated dilation (%) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Carotid-Femoral Pulse Wave Velocity
Description
Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Blood pressure
Description
Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Peripheral Neuropathy
Description
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.
Time Frame
22 weeks
Title
Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire
Description
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
Time Frame
22 weeks
Title
Health Related Quality of Life as Measured by the FACT-O Questionnaire
Description
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
Time Frame
22 weeks
Title
Quality of Life as Assessed by the Short Form Health Survey (SF-36)
Description
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.
Time Frame
22 weeks
Other Pre-specified Outcome Measures:
Title
NTproBNP
Description
Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Inflammation
Description
C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Lipids
Description
A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
Title
Insulin
Description
Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health at all 3 time points
Time Frame
22 weeks
Title
Fasting Blood Glucose
Description
Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health at pre-surgery, pre-chemotherapy, and post-chemotherapy
Time Frame
22 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siddhartha S Angadi, PhD
Phone
434-243-7466
Email
ssa2w@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Modesitt, MD
Email
SCM6H@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siddhartha S Angadi, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia University Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddhartha S Angadi, PhD
First Name & Middle Initial & Last Name & Degree
Susan Modesitt, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Preconditioning in Ovarian Cancer
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