Breast CancerNCT05786014
The Effects of Two Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
A study testing High Intensity Interval Exercise and Moderate Intensity Walking in people with Breast Cancer and Cardiotoxicity, 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, inflammatory responses, 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
- Breast Cancer, Cardiotoxicity, Cardiovascular Diseases
- What is being tested?
- High Intensity Interval Exercise and Moderate Intensity Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 26 Aug 2024
- 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
- diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC (Docetaxel/Cyclophosphamide), AC (Doxorubicin/Cyclophosphamide followed by Paclitaxel), TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab), TCH (Docetaxel/Carboplatin/Trastuzumab) with or without Pembrolizumab)
- Physician clearance for exercise training
- Speak/understand English
Who cannot join
- previous treatment with cardiotoxic chemotherapy
- medical/orthopedic comorbidities that preclude stationary cycling
- significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
- unstable angina or myocardial infarction within 4-weeks prior to treatment
- complex ventricular arrhythmias or New York Heart Association class IV symptoms
- symptomatic severe aortic stenosis
Show all 16Show fewer
- acute pulmonary embolus
- acute myocarditis
- History of untreated high-risk proliferative retinopathy
- History of retinal hemorrhage
- uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg)
- severe baseline electrolyte abnormalities
- medication non-compliance
- uncontrolled metabolic disease (diabetes with fasting blood sugar >300 mg/dl, thyrotoxicosis, myxedema)
- symptomatic peripheral vascular disease
- Pregnant women
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: A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
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, inflammatory responses, and quality of life.
Read the detailed description
Breast cancer is the most common malignancy affecting women in the US and survivors experience long-term health effects of chemotherapy. Exercise training is an efficacious treatment for preserving functional capacity and has shown promise in mitigating cardiac toxicity of breast cancer chemotherapy. However, supervised exercise is not a practical solution for all breast cancer survivors, as medically monitored exercise facilities are poorly dispersed in the US and poorly utilized by cancer patients. To improve reach of these programs, remotely monitoring exercise sessions may be necessary. However, effects of remotely-monitored exercise conditioning before and during adjuvant/neoadjuvant chemotherapy on cardiotoxic outcomes are unknown. Our study aims to address this gap by testing the feasibility of two types of remotely-monitored exercise interventions, an exercise bicycle intervention compared to a brisk walking intervention, in 20 UVA Breast Cancer Clinic patients undergoing cardiotoxic chemotherapies. Remotely-monitored exercise training will start one week prior to chemotherapy (preconditioning) and continue throughout adjuvant or neoadjuvant chemotherapy (which is typically 4 months in duration). Our multidisciplinary research team proposes four aims: 1) Determine the extent to which eligible patients can be successfully recruited, randomized, and retained; 2) Assess VO2peak, echocardiography derived left ventricular ejection fraction and left ventricular global longitudinal strain among these patients at baseline and at ~4 months; 3) Examine treatment engagement and intervention acceptability; and 4) Explore the relationship between engagement in the exercise training and psychosocial function.
- Conditions
- Breast Cancer, Cardiotoxicity, Cardiovascular Diseases
- Being tested
- High Intensity Interval Exercise, Moderate Intensity Walking
- Keywords
- chemotherapy, cardiotoxicity, cardiorespiratory fitness
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Cardiovascular Diseases
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 Cycling Intervention arm will undergo two training sessions at the exercise physiology core lab to ensure participants understand the intervention exercise protocol and can safely perform it at home. The Participants will perform high intensity 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. Subjects will then perform this exercise training at their own homes using recumbent exercise bikes provided by the investigators for that purpose. Study investigators will check in up to weekly with participants and remotely track exercise data and compliance via activity tracker.
Moderate Intensity WalkingBehavioural
Patients will undergo two familiarization training sessions in the exercise physiology core lab to ensure participants understands the walking intervention and can properly gauge intensity. Participants will be asked to walk briskly or jog so they achieve a moderate intensity (70-75% of the maximal heart rate achieved during the VO2peak test). The goal for participants in this condition will be to accumulate at least 150-minutes per week at this heart rate by brisk walking or jogging. Participants will also receive a gift card to be used to purchase a pair of walking shoes to facilitate their engagement.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Walking | Experimental | Subjects allocated to moderate intensity walking will be given a gift card to purchase a paid of running shoes. A chest-based heart rate monitor and an activity tracker watch will be provided. Subjects will aim to achieve 150 minutes a week of moderate intensity walking. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity. Receives: Behavioral: Moderate Intensity Walking |
| High Intensity Interval Exercise | Experimental | Subjects will receive a recumbent bike to be delivered and assembled to their home as well as a heart rate monitor and activity tracker. Subjects will undergo high intensity interval exercise 3 days a week, with the goal of achieving 85-90% of their heart rate max. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity. Receives: Behavioral: High Intensity Interval Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Retention Percentage
This is a feasibility study designed to determine the extent to which eligible patients can be successfully recruited, randomized, and retained. Endpoint data will be used to justify and provide point estimates for a fully powered study. Retention will be measured as a percentage of those enrolled who complete the study interventions.
Measured: 22 Weeks
Secondary outcomes (9)
VO2peak
Change in VO2peak (L/min) measured at pre-chemotherapy and post chemotherapy
Measured: 22 Weeks
Global Longitudinal Strain
Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at 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-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-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-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-chemotherapy and post-chemotherapy
Measured: 22 Weeks
Blood pressure
Brachial systolic and diastolic blood pressures (mmHg) will be measured at baseline and post-chemotherapy.
Measured: 22 Weeks
Lipid panels
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-chemotherapy and post-chemotherapy
Measured: 22 Weeks
Inflammation/Immune cell concentrations in peripheral circulation.
Various markers of inflammation and immune cells will be measured at baseline, pre-chemo (following exercise pre-conditioning), midway through patient's prescribed treatment, and post-intervention to determine changes.
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 posted27 Mar 2023
- Study start1 Apr 2023
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786014
- Sponsor's protocol ID
- 220287
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weeldreyer NR, Ellison CC, Mabalot MB, Helms CE, Nealy ZB, Leicht ZS, Abbate A, Brenin CM, Dillon PM, Millard T, Krukowski RA, Zoellner JM, Angadi SS. The effect of two remote exercise programs on cardiorespiratory fitness, cardiac function, and vascular health in patients with breast cancer. Physiol Rep. 2026 Feb;14(4):e70787. doi: 10.14814/phy2.70787.
PubMed 41704018
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
- A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
- ClinicalTrials.gov ID
- NCT05786014
- Acronym / sponsor ID
- 220287
- Conditions
- Breast Cancer, Cardiotoxicity, Cardiovascular Diseases
- Keywords
- chemotherapy, cardiotoxicity, cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 27 Mar 2023 (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, inflammatory responses, and quality of life.
Detailed description
Breast cancer is the most common malignancy affecting women in the US and survivors experience long-term health effects of chemotherapy. Exercise training is an efficacious treatment for preserving functional capacity and has shown promise in mitigating cardiac toxicity of breast cancer chemotherapy. However, supervised exercise is not a practical solution for all breast cancer survivors, as medically monitored exercise facilities are poorly dispersed in the US and poorly utilized by cancer patients. To improve reach of these programs, remotely monitoring exercise sessions may be necessary. However, effects of remotely-monitored exercise conditioning before and during adjuvant/neoadjuvant chemotherapy on cardiotoxic outcomes are unknown. Our study aims to address this gap by testing the feasibility of two types of remotely-monitored exercise interventions, an exercise bicycle intervention compared to a brisk walking intervention, in 20 UVA Breast Cancer Clinic patients undergoing cardiotoxic chemotherapies. Remotely-monitored exercise training will start one week prior to chemotherapy (preconditioning) and continue throughout adjuvant or neoadjuvant chemotherapy (which is typically 4 months in duration). Our multidisciplinary research team proposes four aims: 1) Determine the extent to which eligible patients can be successfully recruited, randomized, and retained; 2) Assess VO2peak, echocardiography derived left ventricular ejection fraction and left ventricular global longitudinal strain among these patients at baseline and at ~4 months; 3) Examine treatment engagement and intervention acceptability; and 4) Explore the relationship between engagement in the exercise training and psychosocial function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Walking | Experimental | Behavioral: Moderate Intensity WalkingSubjects allocated to moderate intensity walking will be given a gift card to purchase a paid of running shoes. A chest-based heart rate monitor and an activity tracker watch will be provided. Subjects will aim to achieve 150 minutes a week of moderate intensity walking. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity. |
| High Intensity Interval Exercise | Experimental | Behavioral: High Intensity Interval ExerciseSubjects will receive a recumbent bike to be delivered and assembled to their home as well as a heart rate monitor and activity tracker. Subjects will undergo high intensity interval exercise 3 days a week, with the goal of achieving 85-90% of their heart rate max. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or over
- diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC (Docetaxel/Cyclophosphamide), AC (Doxorubicin/Cyclophosphamide followed by Paclitaxel), TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab), TCH (Docetaxel/Carboplatin/Trastuzumab) with or without Pembrolizumab)
- Physician clearance for exercise training
- Speak/understand English
Key exclusion criteria (16 listed)
- previous treatment with cardiotoxic chemotherapy
- medical/orthopedic comorbidities that preclude stationary cycling
- significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
- unstable angina or myocardial infarction within 4-weeks prior to treatment
- complex ventricular arrhythmias or New York Heart Association class IV symptoms
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 Cycling Intervention arm will undergo two training sessions at the exercise physiology core lab to ensure participants understand the intervention exercise protocol and can safely perform it at home. The Participants will perform high intensity 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. Subjects will then perform this exercise training at their own homes using recumbent exercise bikes provided by the investigators for that purpose. Study investigators will check in up to weekly with participants and remotely track exercise data and compliance via activity tracker. | Behavioural | High Intensity Interval Exercise |
| Moderate Intensity WalkingPatients will undergo two familiarization training sessions in the exercise physiology core lab to ensure participants understands the walking intervention and can properly gauge intensity. Participants will be asked to walk briskly or jog so they achieve a moderate intensity (70-75% of the maximal heart rate achieved during the VO2peak test). The goal for participants in this condition will be to accumulate at least 150-minutes per week at this heart rate by brisk walking or jogging. Participants will also receive a gift card to be used to purchase a pair of walking shoes to facilitate their engagement. | Behavioural | Moderate Intensity Walking |
Primary outcome
Subject Retention Percentage
Time frame: 22 Weeks
This is a feasibility study designed to determine the extent to which eligible patients can be successfully recruited, randomized, and retained. Endpoint data will be used to justify and provide point estimates for a fully powered study. Retention will be measured as a percentage of those enrolled who complete the study interventions.
9 secondary outcomes
VO2peak
Time frame: 22 Weeks
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
Lipid panels
Time frame: 22 Weeks
Inflammation/Immune cell concentrations in peripheral circulation.
Time frame: 22 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 41704018Weeldreyer NR, Ellison CC, Mabalot MB, Helms CE, Nealy ZB, Leicht ZS, Abbate A, Brenin CM, Dillon PM, Millard T, Krukowski RA, Zoellner JM, Angadi SS. The effect of two remote exercise programs on cardiorespiratory fitness, cardiac function, and vascular health in patients with breast cancer. Physiol Rep. 2026 Feb;14(4):e70787. doi: 10.14814/phy2.70787.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Moderate Intensity Walking in people with Breast Cancer and Cardiotoxicity, 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 4 inclusion and 16 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: finished, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject Retention Percentage (time frame: 22 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786014, which also lists 1 linked publication.
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.