ClinicalTrials.gg
Not yet recruitingNCT07517224Updated Sep 16, 2026

Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer

An interventional study of Aerobic Exercise in Breast Cancer Survivors, sponsored by Loyola University. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Loyola University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study 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, 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.
02

Conditions studied

  • Breast Cancer Survivors

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti- agents.
  2. Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
  3. Sedentary by self-reporting inactivity (\<90 min of moderate or vigorous exercise per week)
  4. Weight ≤154 kg
  5. Willing to complete all study activities
  6. Able to safely participate in moderate aerobic exercise.

Exclusion criteria

Exclusion criteria:

  1. Current pregnant and lactating patients. Must have completed lactation prior to study start.
  2. disease.
  3. 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, below 50%.
  4. Non-English speaking
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Exercise Intervention

    Other: Aerobic Exercise

Interventions

  • OtherAerobic Exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to immediately after first visit

  2. 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.

    Time frame: From enrollment to the end of intervention at 8 weeks

  3. 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.

    Time frame: From enrollment to the end of intervention at 8 weeks

  4. 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.

    Time frame: From enrollment to the end of intervention at 8 weeks"

  5. 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.

    Time frame: 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.

    Time frame: From enrollment to the end of intervention at 8 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2031, 55 months later.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 55 months is above that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2026
First posted
Apr 8, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
May 1, 2031
CompletionEst.
May 1, 2035
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07517224
Lead sponsor
Loyola University
Responsible party
Georgios Grigoriadis (Assistant Professor, Loyola University) — Principal investigator
First posted
Apr 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 1, 2031 (estimated)
Completion
May 1, 2035 (estimated)
Last update
Sep 16, 2026

Study contacts

Georgios Grigoriadis, PhD
Contact
ggrigoriadis@luc.edu
773-508-3658

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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