Anthracycline-induced Cardiotoxicity, Cardiotoxicity, Cardiovascular Diseases, Childhood Cancer Survivors
Conditions
Brief summary
This trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.
Detailed description
This phase 1, pilot, randomized clinical trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines. Participants will be randomized into 1 of 2 study groups: Arm 1: High-intensity interval training (HIIT) or Arm 2: moderate intensity continuous training (MICT). The research study procedures include screening for eligibility, in-clinic visits, questionnaires, measurements of height, weight, waist, and hip circumference, blood pressure, cardiopulmonary fitness, activity measurements, blood tests, and electrocardiograms (ECGs). Participation in this research study is expected to last about 4 months. It is expected that about 20 people will take part in this research study.
Interventions
BEHAVIORALHIIT Exercise Program
Exercise program with stationary bike via the Zoom platform.
BEHAVIORALMICT Exercise Program
Exercise program with stationary bike via the Zoom platform.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Current age at study initiation 18-39 years. * Cancer diagnosis at age ≤ 18 years. * Previous exposure to any dose of anthracyclines. * Are ≥2 years post-treatment and in remission without relapse after cancer directed therapy. * Eastern Cooperative Oncology Group Performance Status = 0 * Oncology survivorship provider clearance to participate in exercise * No self-reported comorbidities or contraindications that prohibit the undertaking of high intensity exercise (e.g., severe valvular heart disease) * Sedentary (i.e., currently participates in ≤ 60 minutes of structured high or moderate intensity exercise/week) determined by self-report during screening using the Godin Leisure Time Exercise Questionnaire * Speak English * Willing to travel to Dana-Farber Cancer Institute for necessary data collection
Exclusion criteria
* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. * Patients who are pregnant. * Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. * Patients receiving treatment for other active malignancies (except basal cell carcinoma). * Subjects who in the opinion of the investigators, may not be able to comply with the safety monitoring requirements of the study. * Unable to travel to DFCI Longwood campus for necessary data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO₂max | Baseline (Week 0) and post-intervention (Week 17) | Change in peak oxygen uptake (VO₂max) during a graded cycle cardiopulmonary exercise test (CPET), reported as VO₂max (mL/kg/min), derived from expired gas analysis (averaging interval per prespecified CPET analysis approach). |
| Change in average E/e' ratio | Baseline (Week 0) and post-intervention (Week 17) | Average E/e' ratio assessed by echocardiography using Doppler methods per ASE/EACVI guidance. E is the early diastolic transmitral inflow velocity (pulsed-wave Doppler) and e' is early diastolic mitral annular tissue velocity (tissue Doppler); average e' is typically the mean of septal and lateral e'. Reported as change from baseline to post-intervention. |
| Change in septal mitral annular e' velocity | Baseline (Week 0) and post-intervention (Week 17) | Septal e' velocity measured by tissue Doppler imaging at the septal mitral annulus. Reported as change from baseline to post-intervention. Units: cm/s (or m/s). |
| Change in lateral mitral annular e' velocity | Baseline (Week 0) and post-intervention (Week 17) | Lateral e' velocity measured by tissue Doppler imaging at the lateral mitral annulus. Reported as change from baseline to post-intervention. Units: cm/s (or m/s). |
| Change in left atrial maximum volume index (LAVImax) | Baseline (Week 0) and post-intervention (Week 17) | Maximum left atrial volume indexed to body surface area (mL/m²) measured by 2D echocardiography (e.g., biplane method of disks). Reported as change from baseline to post-intervention. |
| Change in peak tricuspid regurgitation velocity | Baseline (Week 0) and post-intervention (Week 17) | Peak tricuspid regurgitation (TR) jet velocity measured by continuous-wave Doppler. Reported as change from baseline to post-intervention. Units: m/s. |
| Change in left ventricular global longitudinal strain (LV GLS) | Baseline (Week 0) and post-intervention (Week 17) | LV global longitudinal strain measured by 2D speckle-tracking echocardiography (typically averaged across LV segments from apical views). Reported as change from baseline to post-intervention. Units: %. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Dieli-Conwright
Dana-Farber Cancer Institute
Outcome results
None listed