Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

Not Applicable

Recruiting

• Conditions: Breast Cancer; Disability Physical; Heart Failure; Cardiotoxicity

• Registration Number: NCT06595147
• Lead Sponsor: University of Alberta

Brief Summary

The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged \>60 years old who previously received chemotherapy drugs that can affect the heart.

The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-06
• Study Start: 2024-07-01
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age ≥60 years
• Previously diagnosed with early-stage (I-III) BC
• Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).

Exclusion Criteria

• Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease
• Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
• Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
• Currently performing structured exercise training (defined as ≥30 mins/day of moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
• Are unwilling to be randomized to either ExT or STRETCH

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peak arterio-venous oxygen content difference	12 Weeks	Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Peak cardiac output	12 Weeks	Peak exercise cardiac output assessed using whole-body exercise MRI

Secondary Outcome Measures

Name	Time	Method
Peak diffusive muscle oxygen conductance	12 Weeks	Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI
Peak stroke volume	12 Weeks	Peak exercise stroke volume assessed using whole-body exercise MRI
Aerobic endurance	12 Weeks	Walk distance measured during a six minute walk test
Physical Function	12 Weeks	Short physical performance battery total score (Score from 0 to 12, where higher scores represent better function)
Skeletal muscle volume	12 Weeks	Muscle volume of the thigh and lower leg from MRI
Skeletal muscle myosteatosis	12 Weeks	Muscular fat fraction of the thigh and lower leg from MRI
Skeletal muscle fibrosis	12 Weeks	Muscular fibrosis of the thigh and lower leg measured from MRI T1 values
Calf muscle aerobic capacity	12 Weeks	Peak muscle oxygen uptake from maximal plantar flexion exercise MRI
Calf muscle oxygen extraction	12 Weeks	Peak muscle arterio-venous oxygen difference from maximal plantar flexion exercise MRI
Calf muscle metabolism	12 Weeks	Exercise phosphate and phosphocreatine responses during plantar flexion exercise 31P magnetic resonance spectroscopy
10-year Framingham Risk Score	12 Weeks	10-year Framingham Risk Score will be calculated from participant Sex, Age, HDL-cholesterol, Total Cholesterol, Resting Systolic Blood Pressure, Smoking Status and presence of Diabetes. The score ranges from 0% to 100% where higher scores indicate higher CVD risk.
Peak volume of oxygen uptake	12 Weeks	Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test
Calf muscle oxygen diffusive conductance	12 Weeks	Peak muscle oxygen diffusive conductance from maximal plantar flexion exercise MRI

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada