Ovarian CancerNCT05029154
Exercise Preconditioning in Ovarian Cancer
A study testing High intensity interval exercise in people with Ovarian Cancer, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- High intensity interval exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Virginia University Hospital
Charlottesville, Virginia, 22903
About this study
Official title: Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- High intensity interval exercise, Attention control
- Keywords
- Cardiotoxicity, Ovarian Cancer, Exercise Training, Chemotherapy, Cardiovascular toxicity ovarian cancer chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval exerciseBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Patients in the exercise group will perform interval training 3 days per week. Receives: Behavioral: High intensity interval exercise |
| Attention Control | Placebo comparator | Physical activity education and physical activity monitoring. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Peak
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
Measured: 22 weeks
Secondary outcomes (10)
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
Measured: 22 weeks
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
Measured: 22 weeks
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
Measured: 22 weeks
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
Measured: 22 weeks
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
Measured: 22 weeks
Blood pressure
Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy
Measured: 22 weeks
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.
Measured: 22 weeks
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
Measured: 22 weeks
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
Measured: 22 weeks
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.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start21 Oct 2021
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Why it stopped: Accrual not meeting pre-specified numbers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddartha Angadi, University of Virginia
- Investigators
- Siddhartha S Angadi, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029154
- Sponsor's protocol ID
- HSR210169
- Status last verified
- Jun 2025
- First submitted
- 17 Aug 2021
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity
- ClinicalTrials.gov ID
- NCT05029154
- Acronym / sponsor ID
- HSR210169
- Conditions
- Ovarian Cancer
- Keywords
- Cardiotoxicity, Ovarian Cancer, Exercise Training, Chemotherapy, Cardiovascular toxicity ovarian cancer chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual not meeting pre-specified numbers.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: High intensity interval exercisePatients in the exercise group will perform interval training 3 days per week. |
| Attention Control | Placebo comparator | Behavioral: Attention controlPhysical activity education and physical activity monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval exercisePatients 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. | Behavioural | Exercise |
| Attention controlPatients 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. | Behavioural | Attention Control |
Primary outcome
VO2 Peak
Time frame: 22 weeks
Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy
10 secondary outcomes
Global Longitudinal Strain
Time frame: 22 weeks
Ejection Fraction
Time frame: 22 weeks
Diastolic Function
Time frame: 22 weeks
Brachial Artery Endothelium-Dependent Flow-Mediated Dilation
Time frame: 22 weeks
Carotid-Femoral Pulse Wave Velocity
Time frame: 22 weeks
Blood pressure
Time frame: 22 weeks
Peripheral Neuropathy
Time frame: 22 weeks
Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire
Time frame: 22 weeks
Health Related Quality of Life as Measured by the FACT-O Questionnaire
Time frame: 22 weeks
Quality of Life as Assessed by the Short Form Health Survey (SF-36)
Time frame: 22 weeks
Results and safety
The study was stopped early (reason given: Accrual not meeting pre-specified numbers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siddhartha S Angadi, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval exercise in people with Ovarian Cancer, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Accrual not meeting pre-specified numbers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 Peak (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.