Rowing Following Breast Cancer Chemotherapy

Breast Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848141
• Other study ID #: IRB202201237
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: Demetra Christou, PhD
• Phone: 352-294-1746
• Email: ddchristou[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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 chemotherapy 6 to 18 months prior to study enrollment

• absence of contraindications to exercise or study participation

• study clinician approval

Exclusion Criteria:

• do not meet inclusion criteria

• completed chemotherapy and/or other cancer treatment (i.e., surgery or radiation) within past 6 months. 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 past 6 months.

• receiving or scheduled to receive radiation therapy during study participation

• scheduled to receive surgery during study participation

• receiving or scheduled to receive chemotherapy 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)

• body mass index = 40 kg/m2

• 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 aerobic exercise training in previous 6 months

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Integrative Cardiovasculal Physiology Laboratory, University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brachial FMD	Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.	Baseline, Following 12 weeks of supervised exercise training
Primary	Change in global longitudinal strain	Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.	Baseline, Following 12 weeks of supervised exercise training
Primary	% completed vs. planned exercise frequency	We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.	Throughout the 12 weeks of supervised exercise training
Primary	% completed vs. planned exercise duration	We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.	Throughout the 12 weeks of supervised exercise training
Primary	% completed vs. planned exercise intensity	We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.	Throughout the 12 weeks of supervised exercise training
Primary	Number of participants who experience adverse event as defined by most recent CTCAE	To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.	Throughout the 12 weeks of supervised exercise training