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Trial Title:
Rowing Following Breast Cancer Chemotherapy
NCT ID:
NCT05848141
Condition:
Breast Cancer Survivors
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise training
Description:
This is a single site center-based supervised exercise intervention.
Arm group label:
Indoor Rowing
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.
Criteria for 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
Gender:
Female
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Integrative Cardiovasculal Physiology Laboratory, University of Florida
Address:
City:
Gainesville
Zip:
32611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Demetra Christou, PhD
Phone:
352-294-1746
Email:
ddchristou@ufl.edu
Start date:
February 26, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
University of Florida
Agency class:
Other
Source:
University of Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848141
