Breast Cancer SurvivorsNCT05848141
Rowing Following Breast Cancer Chemotherapy
A study testing Exercise training in people with Breast Cancer Survivors, run by University of Florida at 1 site in United States.
Trial summary
There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to Dec 2027
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- female based on biological sex
- 40 to 80 years of age
- completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation
- absence of contraindications to exercise or study participation
- study clinician approval
Who cannot join
- do not meet inclusion criteria
- receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation
- lymphedema stage ≥ 2 prior to study enrolment
- any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
- consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Integrative Cardiovasculal Physiology Laboratory, University of Florida
Gainesville, Florida, 32611
Demetra Christou, PhD, 352-294-1746, ddchristou@ufl.edu
About this study
Official title: Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy
There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.
- Conditions
- Breast Cancer Survivors
- Being tested
- Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
This is a single site center-based supervised exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Indoor Rowing | Experimental | Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks. Receives: Behavioral: Exercise training |
| Usual Care | No intervention | Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial FMD
Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Measured: Baseline, Following 12 weeks of supervised exercise training
Change in global longitudinal strain
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
Measured: Baseline, Following 12 weeks of supervised exercise training
% completed vs. planned exercise frequency
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Measured: Throughout the 12 weeks of supervised exercise training
% completed vs. planned exercise duration
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Measured: Throughout the 12 weeks of supervised exercise training
% completed vs. planned exercise intensity
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Measured: Throughout the 12 weeks of supervised exercise training
Number of participants who experience adverse event as defined by most recent CTCAE
To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
Measured: Throughout the 12 weeks of supervised exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start26 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by University of FloridaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848141
- Sponsor's protocol ID
- IRB202201237
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2023
- Last updated
- 27 Aug 2026
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy
- ClinicalTrials.gov ID
- NCT05848141
- Acronym / sponsor ID
- IRB202201237
- Conditions
- Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 May 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.
There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indoor Rowing | Experimental | Behavioral: Exercise trainingResearch participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks. |
| Usual Care | No intervention | –Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- female based on biological sex
- 40 to 80 years of age
- completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation
- absence of contraindications to exercise or study participation
Key exclusion criteria (6 listed)
- do not meet inclusion criteria
- receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation
- lymphedema stage ≥ 2 prior to study enrolment
- any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
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 |
|---|---|---|
| Exercise trainingThis is a single site center-based supervised exercise intervention. | Behavioural | Indoor Rowing |
Primary outcome
Change in brachial FMD
Time frame: Baseline, Following 12 weeks of supervised exercise training
Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Change in global longitudinal strain
Time frame: Baseline, Following 12 weeks of supervised exercise training
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
% completed vs. planned exercise frequency
Time frame: Throughout the 12 weeks of supervised exercise training
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
% completed vs. planned exercise duration
Time frame: Throughout the 12 weeks of supervised exercise training
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
% completed vs. planned exercise intensity
Time frame: Throughout the 12 weeks of supervised exercise training
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Number of participants who experience adverse event as defined by most recent CTCAE
Time frame: Throughout the 12 weeks of supervised exercise training
To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
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 27 Aug 2026.
- 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.
Demetra Christou, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Breast Cancer Survivors, run by University of Florida 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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?
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 Demetra Christou, PhD (352-294-1746, ddchristou@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brachial FMD (time frame: Baseline, Following 12 weeks of supervised exercise training). The study lists 6 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 27 Aug 2026.