Impact of Exercise Intensity on Cardiac Health in Young Adult Survivors of Childhood Cancer: The PULSE Trial

N/AActive Not RecruitingNCT07442578

Dana-Farber Cancer Institute20 enrolled

Overview

This trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Childhood Cancer Survivors Cardiotoxicity Cardiovascular Diseases Anthracycline-induced Cardiotoxicity

Interventions

HIIT Exercise ProgramBEHAVIORAL

Exercise program with stationary bike via the Zoom platform.

MICT Exercise ProgramBEHAVIORAL

Exercise program with stationary bike via the Zoom platform.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in average E/e' ratio

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.