Exercise Preconditioning in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029154
• Other study ID #: HSR210169
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: University of Virginia
• Contact: Siddhartha S Angadi, PhD
• Phone: 434-243-7466
• Email: ssa2w[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• High intensity interval exercise
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.
• Attention control
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.

Locations

Country	Name	City	State
United States	University of Virginia University Hospital	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NTproBNP	Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre-surgery, pre-chemotherapy, and post-chemotherapy	22 weeks
Other	Inflammation	C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured at pre-surgery, pre-chemotherapy, and post-chemotherapy	22 weeks
Other	Lipids	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	22 weeks
Other	Insulin	Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health at all 3 time points	22 weeks
Other	Fasting Blood Glucose	Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health at pre-surgery, pre-chemotherapy, and post-chemotherapy	22 weeks
Primary	VO2 Peak	Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy	22 weeks
Secondary	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	22 weeks
Secondary	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	22 weeks
Secondary	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	22 weeks
Secondary	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	22 weeks
Secondary	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	22 weeks
Secondary	Blood pressure	Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy	22 weeks
Secondary	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.	22 weeks
Secondary	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	22 weeks
Secondary	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	22 weeks
Secondary	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.	22 weeks