A Study to Evaluate Left and Right Ventricular Function in Relation to Exercise Capacity in Breast Cancer Survivors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-008833
Sponsor Protocol Number: 19-008833
About this study
The purpose of this study is to determine if exercise improves cardiac remodeling as a way to mitigate the negative effects of chemotherapy and radiation therapy which lead to reduced exercise tolerance.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Females ≥ 18 years of age.
- Females treated for breast cancer (BC) with left breast radiation and chemotherapy which must have included an anthracycline dosed at 60 mg/m2 for 4 cycles.
- Date of last exposure to chemotherapy or radiation therapy > 1 year.
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Mechanical ventilation
- Acute or chronic renal failure (creatinine clearance < 30 ml/min or on renal replacement therapy
- Inability to perform MRI (claustrophobia, severe morbid obesity, non-MRI compatible implanted devices
- Inability to exercise
- Significant arrhythmia that precludes adequate ECG-gating for the MRI (atrial fibrillation with a highly variable cycle length)
- Left ventricular systolic dysfunction (ejection fraction < 50%) or diastolic failure based on Framingham criteria for heart failure with preserved ejection fraction.
- Significant left-sided valvular disease (moderate to severe aortic valve stenosis, mitral valve stenosis, aortic regurgitation, mitral regurgitation, or prior valve surgery) .
- History of congenital heart defect with or without repair.
- Exposure to chemotherapy for a malignancy other than breast cancer.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brian Shapiro, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available