Clinical trial NCT05029154: Exercise Preconditioning in Ovarian Cancer
Official title: Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Cardiotoxicity
Ovarian Cancer
Exercise Training
Chemotherapy
Cardiovascular toxicity ovarian cancer chemotherapy
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized control trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: VO2 Peak
timeFrame: 22 weeks
Secondary outcomes:
measure: Global Longitudinal Strain
timeFrame: 22 weeks
measure: Ejection Fraction
timeFrame: 22 weeks
measure: Diastolic Function
timeFrame: 22 weeks
measure: Brachial Artery Endothelium-Dependent Flow-Mediated Dilation
timeFrame: 22 weeks
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: 22 weeks
measure: Blood pressure
timeFrame: 22 weeks
measure: Peripheral Neuropathy
timeFrame: 22 weeks
measure: Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire
timeFrame: 22 weeks
measure: Health Related Quality of Life as Measured by the FACT-O Questionnaire
timeFrame: 22 weeks
measure: Quality of Life as Assessed by the Short Form Health Survey (SF-36)
timeFrame: 22 weeks
Other outcomes:
measure: NTproBNP
timeFrame: 22 weeks
measure: Inflammation
timeFrame: 22 weeks
measure: Lipids
timeFrame: 22 weeks
measure: Insulin
timeFrame: 22 weeks
measure: Fasting Blood Glucose
timeFrame: 22 weeks
Locations:
city: Charlottesville
country: United States
facility: University of Virginia University Hospital
state: Virginia
Study officials:
affiliation: University of Virginia
name: Siddhartha S Angadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: