Rowing Following Breast Cancer Chemotherapy

University of Florida

Status: Enrolling

Conditions: Breast Cancer Survivors

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05848141

IRB202201237

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Indoor Rowing

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise training

Usual Care

No Intervention group

Description:

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