Exercise Preconditioning in Ovarian Cancer

University of Virginia

Status: Terminated

Conditions: Ovarian Cancer

Treatments: Behavioral: Attention control; Behavioral: High intensity interval exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05029154

HSR210169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

Exercise

Experimental group

Description:

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

Treatment:

Behavioral: High intensity interval exercise

Attention Control

Placebo Comparator group

Description:

Physical activity education and physical activity monitoring.

Treatment:

Behavioral: Attention control