Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

Technical University of Munich

Status: Invitation-only

Conditions: Cardiovascular Diseases; Pediatric Cancer

Treatments: Diagnostic Test: Exercise stress echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT05261256

German Heart Foundation

Details and patient eligibility

About

This study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatment during childhood and adolescence.

Full description

Cardiovascular late effects following treatment for pediatric cancer are problematic. Early detection of subclinical changes is hardly possible using conventional diagnostic methods, but seems to be feasible during physical strain (exercise stress echocardiography).

This feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). The heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects.

Secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for all participants:

• Aged between 10 and 25 years
• Body height of ≥1,40m (required for performing the examination on the semi supine bicycle ergometer)
• Signed informed assent (minor participant) and consent (legal guardian and full-aged participant)

Additional inclusion criteria for participants following cancer treatment:

• Completion of acute cancer treatment with anthracyclines and/or chest radiation
• End of treatment 12 months and five years ago (± three months)
• Medical approval for study participation

Additional inclusion criteria for healthy control subjects:

• Appropriate as matched pair with respect to age and gender

Exclusion Criteria:

• Known cardiovascular diseases (incoherent with cardiotoxic treatment)
• Inability to follow study instructions (e.g., mental retardation, language)
• Acute orthopedic injury (e.g., bone fracture) or orthopedic impairments that preclude examination on a bicycle ergometer (e.g., instable prosthetic device)

All participants receive a basic physical and cardiological examination at rest as part of the study protocol to ensure capability before performing the exercise stress echocardiography.

Trial design

80 participants in 2 patient groups

Participants treated for pediatric cancer

Description:

This group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment.

Treatment:

Diagnostic Test: Exercise stress echocardiography

Healthy control subjects

Description:

This group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects.

Treatment:

Diagnostic Test: Exercise stress echocardiography