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NCT Number: NCT06595147

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Disability Physical Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G1C9, Canada

Location status: Recruiting

Location contact

Edith Pituskin, PhD

SUB_INVESTIGATOR

Margaret McNeely, PhD

SUB_INVESTIGATOR

Mark Haykowsky, PhD

PRINCIPAL_INVESTIGATOR

Nathan Weeldreyer, PhD

CONTACT

[email protected]

616.566.6756

Richard B Thompson, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Exercise Training

Behavioral

Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.

Group-based Yoga and Stretching

Behavioral

Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.

Primary outcomes

  1. Peak arterio-venous oxygen content difference

    Time frame: 12 Weeks

    Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI

  2. Peak cardiac output

    Time frame: 12 Weeks

    Peak exercise cardiac output assessed using whole-body exercise MRI

Secondary outcomes

  1. Peak volume of oxygen uptake

    Time frame: 12 Weeks

    Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test

  2. Peak diffusive muscle oxygen conductance

    Time frame: 12 Weeks

    Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI

  3. Peak stroke volume

    Time frame: 12 Weeks

    Peak exercise stroke volume assessed using whole-body exercise MRI

  4. Aerobic endurance

    Time frame: 12 Weeks

    Walk distance measured during a six minute walk test

  5. Physical Function

    Time frame: 12 Weeks

    Short physical performance battery total score (Score from 0 to 12, where higher scores represent better function)

  6. Skeletal muscle volume

    Time frame: 12 Weeks

    Muscle volume of the thigh and lower leg from MRI

  7. Skeletal muscle myosteatosis

    Time frame: 12 Weeks

    Muscular fat fraction of the thigh and lower leg from MRI

  8. Skeletal muscle fibrosis

    Time frame: 12 Weeks

    Muscular fibrosis of the thigh and lower leg measured from MRI T1 values

  9. Calf muscle aerobic capacity

    Time frame: 12 Weeks

    Peak muscle oxygen uptake from maximal plantar flexion exercise MRI

  10. Calf muscle oxygen extraction

    Time frame: 12 Weeks

    Peak muscle arterio-venous oxygen difference from maximal plantar flexion exercise MRI

  11. Calf muscle oxygen diffusive conductance

    Time frame: 12 Weeks

    Peak muscle oxygen diffusive conductance from maximal plantar flexion exercise MRI

  12. Calf muscle metabolism

    Time frame: 12 Weeks

    Exercise phosphate and phosphocreatine responses during plantar flexion exercise 31P magnetic resonance spectroscopy

  13. 10-year Framingham Risk Score

    Time frame: 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.

Other outcomes

  1. Habitual Physical Activity

    Time frame: 12 Weeks

    Time spent in moderate-to-vigorous physical activity over 7 days of objective monitoring (Fitbit)

  2. Fasting Lipids

    Time frame: 12 Weeks

    A fasting blood test will be used to measure concentrations of high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol and triglycerides

  3. Fasting Glycaemic Control

    Time frame: 12 Weeks

    A fasting blood test will be used to measure concentrations of fasting plasma glucose and fasting insulin

  4. Fasting Insulin Resistance

    Time frame: 12 Weeks

    Fasting insulin resistance will be calculated from fasting plasma glucose and insulin concentrations using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) method.

  5. C-reactive protein

    Time frame: 12 Weeks

    Plasma concentrations of C-reactive protein will be assessed from a fasting blood test.

  6. Resting blood pressure

    Time frame: 12 Weeks

    Resting systolic and diastolic blood pressure will be measured in the supine position using an automated oscillometric blood pressure cuff.

  7. Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire

    Time frame: 12 Weeks

    Quality of Life, including physical, emotional and social wellbeing and breast cancer related symptom score on the FACT-B questionnaire. Participants will be scored from 0 to 148, where 148 represents the highest quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan Weeldreyer, PhD

CONTACT

[email protected]

616.566.6756

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: BE-FITTER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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