Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study

Conditions
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Cardiovascular Diseases, Pediatric Cancer

Intervention / Treatment
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* Diagnostic Test: Exercise stress echocardiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated for pediatric cancer<br>This group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment. | Diagnostic Test: Exercise stress echocardiography<br>* Study participants perform an exercise stress echocardiography on a semi-supine bicycle ergometer using using a continuous incremental bicycle protocol with a work rate increment every 3 minutes according to gender and weight.<br>|
| Healthy control subjects<br>This group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects. | Diagnostic Test: Exercise stress echocardiography<br>* Study participants perform an exercise stress echocardiography on a semi-supine bicycle ergometer using using a continuous incremental bicycle protocol with a work rate increment every 3 minutes according to gender and weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Criteria 1 - Recruitment Rate | 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. | Throughout study completion, an average of 2 years | 
| Feasibility Criteria 2 - Acceptance | Number of finished and discontinued exercise stress echocardiographies. | Throughout study completion, an average of 2 years | 
| Feasibility Criteria 3 - Data Quality | Number of evaluable examination data. | Throughout study completion, an average of 2 years | 
| Feasibility Criteria 4 - Practicability | Difference between scheduled and required time frame for the single examination. | Throughout study completion, an average of 2 years | 
| Feasibility Criteria 5 - Participants' Feedback | Feedback questionnaire with multiple choice options and free text answers. | Throughout study completion, an average of 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood cancer, Cardiac impairments, Late effects, Early detection, Prevention, Stress echocardiography