Breast Cancer SurvivorsNCT07517224
Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer
A study testing Aerobic Exercise in people with Breast Cancer Survivors, run by Loyola University.
Trial summary
The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors. The main questions it aims to answer are: Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti-HER2 agents.
- Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
- Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
- Weight ≤154 kg
- Willing to complete all study activities
- Able to safely participate in moderate aerobic exercise.
Who cannot join
- Current pregnant and lactating patients. Must have completed lactation prior to study start.
- Metastatic disease.
- Diagnosed cardiovascular disease prior to the initiation of cancer therapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
- Non-English speaking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.
The main questions it aims to answer are:
Read more
- Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents?
- Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?
Participants will:
- Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents.
- Visit our facility three times: before the exercise program, 1 month after, and after the completion of the program.
- Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.
- Conditions
- Breast Cancer Survivors
- Being tested
- Aerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Participants will perform aerobic exercise three times per week for 8 weeks, with each session consisting of 30 minutes at 40-59% of heart rate reserve (HRR). Each session will also include a 10-minute warm-up and a 5-minute cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Not described Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment (Recruitment rate)
Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported.
Measured: From enrollment to immediately after first visit
Participant adherence - Proportion of people considered adherent
Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent.
Measured: From enrollment to the end of intervention at 8 weeks
Retention - Proportion of survivors who completed the study
Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported.
Measured: From enrollment to the end of intervention at 8 weeks
Pulse Wave Velocity
This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots.
This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
Measured: From enrollment to the end of intervention at 8 weeks"
Aortic Blood Pressure
We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels.
This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
Measured: From enrollment to the end of intervention at 8 weeks
Secondary outcomes (1)
Blood Pressure
Participants will be asked to wear a blood pressure cuff on their arm with a small monitoring recording pack (ABPMpro device). The device will take measurements every 2 minutes. Participants will undergo two blood pressure measurements. If the two measurements are not within 5 mmHg for both systolic and diastolic blood pressure, additional measurements will be obtained until this criterion is satisfied. The blood pressure device gives a reliable measurement of the blood pressure, which is an important way to check your heart and blood vessel health This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
Measured: From enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Grigoriadis, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517224
- Sponsor's protocol ID
- 219222
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07517224
- Acronym / sponsor ID
- 219222
- Conditions
- Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 8 Apr 2026 (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 goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.
The main questions it aims to answer are:
- Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents?
- Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?
Participants will:
- Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents.
- Visit our facility three times: before the exercise program, 1 month after, and after the completion of the program.
- Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Aerobic Exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti-HER2 agents.
- Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
- Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
- Weight ≤154 kg
- Willing to complete all study activities
Key exclusion criteria (4 listed)
- Current pregnant and lactating patients. Must have completed lactation prior to study start.
- Metastatic disease.
- Diagnosed cardiovascular disease prior to the initiation of cancer therapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
- Non-English speaking
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 |
|---|---|---|
| Aerobic ExerciseParticipants will perform aerobic exercise three times per week for 8 weeks, with each session consisting of 30 minutes at 40-59% of heart rate reserve (HRR). Each session will also include a 10-minute warm-up and a 5-minute cool-down. | Other | Exercise Intervention |
Primary outcome
Enrollment (Recruitment rate)
Time frame: From enrollment to immediately after first visit
Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported.
Participant adherence - Proportion of people considered adherent
Time frame: From enrollment to the end of intervention at 8 weeks
Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent.
Retention - Proportion of survivors who completed the study
Time frame: From enrollment to the end of intervention at 8 weeks
Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported.
Pulse Wave Velocity
Time frame: From enrollment to the end of intervention at 8 weeks"
This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
Aortic Blood Pressure
Time frame: From enrollment to the end of intervention at 8 weeks
We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
1 secondary outcome
Blood Pressure
Time frame: From enrollment to the end of intervention at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Breast Cancer Survivors, run by Loyola University.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Grigoriadis, PhD (773-508-3658, ggrigoriadis@luc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (Recruitment rate) (time frame: From enrollment to immediately after first visit). The study lists 5 primary outcomes in all. 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 16 Sep 2026.