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Recruiting NCT05848141

Rowing Following Breast Cancer Chemotherapy

No phase Interventional Breast Cancer Survivors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise training.
Who it may be relevant to
Registry conditions: Breast Cancer Survivors. Basic parameters: 40 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Exercise training
    This is a single site center-based supervised exercise intervention.

Primary outcome measures

  • Change in brachial FMD [Time frame: Baseline, Following 12 weeks of supervised exercise training]
  • Change in global longitudinal strain [Time frame: Baseline, Following 12 weeks of supervised exercise training]
  • % completed vs. planned exercise frequency [Time frame: Throughout the 12 weeks of supervised exercise training]
  • % completed vs. planned exercise duration [Time frame: Throughout the 12 weeks of supervised exercise training]
  • % completed vs. planned exercise intensity [Time frame: Throughout the 12 weeks of supervised exercise training]
  • Number of participants who experience adverse event as defined by most recent CTCAE [Time frame: Throughout the 12 weeks of supervised exercise training]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Integrative Cardiovasculal Physiology Laboratory, University of Florida — Gainesville

Identifiers

NCT: NCT05848141 · IRB202201237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗