Clinical trial NCT05848141: Rowing Following Breast Cancer Chemotherapy
Official title: Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivors
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in brachial FMD
timeFrame: Baseline, Following 12 weeks of supervised exercise training
measure: Change in global longitudinal strain
timeFrame: Baseline, Following 12 weeks of supervised exercise training
measure: % completed vs. planned exercise frequency
timeFrame: Throughout the 12 weeks of supervised exercise training
measure: % completed vs. planned exercise duration
timeFrame: Throughout the 12 weeks of supervised exercise training
measure: % completed vs. planned exercise intensity
timeFrame: Throughout the 12 weeks of supervised exercise training
measure: Number of participants who experience adverse event as defined by most recent CTCAE
timeFrame: Throughout the 12 weeks of supervised exercise training
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovasculal Physiology Laboratory, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References: