Rowing Following Breast Cancer Chemotherapy

NCT05848141 | Recruiting DMC

• 1 other identifier: IRB202201237
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Throughout the 12 weeks of supervised exercise training

Study Arms (2)

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.

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.

Interventions

Exercise training BEHAVIORAL

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

Indoor Rowing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of primary invasive non-metastatic breast cancer, stages I-III
• female based on biological sex
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Demetra Christou, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demetra Christou, PhD

CONTACT

352-294-1746; ddchristou@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 8, 2023
• Study Start: February 26, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)