Rowing Following Breast Cancer Chemotherapy

NCT ID: NCT05848141

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Indoor Rowing

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

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

Usual Care

Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demetra Christou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Demetra Christou, PhD

Role: CONTACT

ddchristou@ufl.edu

352-294-1746

Facility Contacts

Demetra Christou, PhD

Role: primary

ddchristou@ufl.edu

352-294-1746

Other Identifiers

IRB202201237

Identifier Type: -

Identifier Source: org_study_id