Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

• Conditions: Cardiovascular Diseases; Pediatric Cancer
• Interventions: Diagnostic Test: Exercise stress echocardiography

• Registration Number: NCT05261256
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-14
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-03-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated for pediatric cancer	Exercise stress echocardiography	This group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment.
Healthy control subjects	Exercise stress echocardiography	This group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects.

Primary Outcome Measures

Name	Time	Method
Feasibility Criteria 3 - Data Quality	Throughout study completion, an average of 2 years	Number of evaluable examination data.
Feasibility Criteria 1 - Recruitment Rate	Throughout study completion, an average of 2 years	The number of children, adolescents and young adults with a history of pediatric cancer who agree to participate compared to the total number approached for this study.
Feasibility Criteria 5 - Participants' Feedback	Throughout study completion, an average of 2 years	Feedback questionnaire with multiple choice options and free text answers.
Feasibility Criteria 2 - Acceptance	Throughout study completion, an average of 2 years	Number of finished and discontinued exercise stress echocardiographies.
Feasibility Criteria 4 - Practicability	Throughout study completion, an average of 2 years	Difference between scheduled and required time frame for the single examination.

Secondary Outcome Measures

Name	Time	Method
Analysis of Echocardiography Marker 3	During the procedure	M-Mode Parameter
Analysis of Echocardiography Marker 2	During the procedure	Ejection Fraction (EF) in %
Reference Values of Healthy Peers	Throughout study completion, an average of 2 years	Assessment of reference values from age- and gender-matched healthy peers (matched pairs).
Physical Activity Level in Healthy Control Subjects	During the procedure	For healthy control subjects: Physical activity questionnaire from the KiGGS study (German Health Interview and Examination Survey for Children and Adolescents).
Analysis of Echocardiography Marker 1	During the procedure	Deformation Parameters in % (global longitudinal strain and circumferencial strain)
Analysis of Echocardiography Marker 4	During the procedure	Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter
Analysis of Echocardiography Marker 5	During the procedure	Left ventricle end diastolic volume (LVEDV) in ml/m²
Cardiorespiratory Fitness	During the procedure	Submaximal oxygen uptake VO2peak (ml/kg/min)
Physical Activity Level post-therapy	During the procedure	For participants with a history of pediatric cancer: Physical activity questionnaire ActiOn post-therapy for the assessment of the amount of moderate-to-vigorous physical activity.

Trial Locations

Locations (1)

Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany; 🇩🇪 Munich, Germany