Role of Aerobic Exercise to Modulate Cardiotoxicity in Long Term Cancer Survivors Exposed to Anthracycline Therapy

NCT04036032 | Completed

• 1 other identifier: 14-110
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

Over 50% of the more than 270,000 childhood cancer survivors in the U.S. have been treated with anthracyclines and thus are at risk of developing cardiotoxicity. The impact of exercise training on LV structure has been extensively studied. Left ventricular hypertrophy and cardiac chamber enlargement with the accompanying ability to generate a large stroke volume are direct results of exercise training. Aerobic exercise therapy offers a non-pharmacological mechanism to modulate multiple gene expression pathways that may promote cardiac remodeling. No prior studies have investigated the efficacy of aerobic exercise in the prevention or treatment of anthracycline-induced cardiotoxicity. We hypothesize that exercise intervention leads to a reverse in adverse cardiac remodeling with improvement of global and regional myocardial function in patients exposed to anthracycline.

Conditions

Cancer; Cardiotoxicity

Outcome Measures

Primary Outcomes (2)

• Small increase in the left and right ventricular volume

  Small increase in the left and right ventricular volume

  Baseline to Week 12

• Small increase in left and right ventricular mass

  Small increase in left and right ventricular mass

  Baseline to Week 12

Interventions

Exercise program OTHER

Encourage to work out 4 to 5 times a week for 3 months. Patient chooses what exercise they would like to do. At YMCA visit for fitness assessments they provide exercise support

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are over 9 years of age and who have had anthracycline chemotherapy treatments that were completed over 2 years ago will be asked to participant in the study. Patients from the oncology clinic and the Stars clinic will be asked to participate.

You may qualify if:

• Long-term childhood cancer survivors greater than 9 years of age\*
• Exposed to anthracycline chemotherapy \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation

You may not qualify if:

• Contraindications to CMRI\*
• Individuals needing sedation to complete the cMRI
• Subject not able to perform stress test.
• Pregnancy\*\*
• Non-English speaking individuals
• Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• Nationwide Children's Hospital: collaborator

Study Sites (2)

CT Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens collected for micro RNA

MeSH Terms

Conditions

Neoplasms; Cardiotoxicity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tiffany L Berthod (Ruiz), MSN, RN, CPN, CCRC

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardio-oncology nurse program manager

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: June 19, 2015
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (2)