Exercise Preconditioning in Ovarian Cancer

NCT05029154 | Terminated DMC

• 1 other identifier: HSR210169
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Cardiotoxicity; Ovarian Cancer; Exercise Training; Chemotherapy; Cardiovascular toxicity ovarian cancer chemotherapy

Outcome Measures

Primary Outcomes (1)

• VO2 Peak

  Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy

  22 weeks

Secondary Outcomes (10)

• Global Longitudinal Strain

  22 weeks

• Ejection Fraction

  22 weeks

• Diastolic Function

  22 weeks

• Brachial Artery Endothelium-Dependent Flow-Mediated Dilation

  22 weeks

• Carotid-Femoral Pulse Wave Velocity

  22 weeks

Other Outcomes (5)

• NTproBNP

  22 weeks

• Inflammation

  22 weeks

• Lipids

  22 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Patients in the exercise group will perform interval training 3 days per week.

Behavioral: High intensity interval exercise

Attention Control

PLACEBO COMPARATOR

Physical activity education and physical activity monitoring.

Behavioral: Attention control

Interventions

High intensity interval exercise BEHAVIORAL

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.

Exercise

Attention control BEHAVIORAL

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.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia University Hospital

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Cardiotoxicity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Siddhartha S Angadi, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm randomized control trial

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 31, 2021
• Study Start: October 21, 2021
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)