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Recruiting

NCT Number: NCT05848141

Rowing Following Breast Cancer 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.

Recruiting

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Key information

Conditions

Breast Cancer Survivors

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Demetra Christou, PhD

CONTACT

[email protected]

352-294-1746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise Training

Behavioral

This is a single site center-based supervised exercise intervention.

Primary outcomes

  1. 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.

  2. 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.

  3. % 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.

  4. % 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.

  5. % 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Demetra Christou, PhD

CONTACT

[email protected]

352-294-1746

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 8, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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