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.
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 Type
OBSERVATIONAL
Enrollment
40
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.
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Munich, Germany
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.
Time frame: Throughout study completion, an average of 2 years
Feasibility Criteria 2 - Acceptance
Number of finished and discontinued exercise stress echocardiographies.
Time frame: Throughout study completion, an average of 2 years
Feasibility Criteria 3 - Data Quality
Number of evaluable examination data.
Time frame: Throughout study completion, an average of 2 years
Feasibility Criteria 4 - Practicability
Difference between scheduled and required time frame for the single examination.
Time frame: Throughout study completion, an average of 2 years
Feasibility Criteria 5 - Participants' Feedback
Feedback questionnaire with multiple choice options and free text answers.
Time frame: Throughout study completion, an average of 2 years
Reference Values of Healthy Peers
Assessment of reference values from age- and gender-matched healthy peers (matched pairs).
Time frame: Throughout study completion, an average of 2 years
Analysis of Echocardiography Marker 1
Deformation Parameters in % (global longitudinal strain and circumferencial strain)
Time frame: During the procedure
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Analysis of Echocardiography Marker 2
Ejection Fraction (EF) in %
Time frame: During the procedure
Analysis of Echocardiography Marker 3
M-Mode Parameter
Time frame: During the procedure
Analysis of Echocardiography Marker 4
Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter
Time frame: During the procedure
Analysis of Echocardiography Marker 5
Left ventricle end diastolic volume (LVEDV) in ml/m²
Time frame: During the procedure
Cardiorespiratory Fitness
Submaximal oxygen uptake VO2peak (ml/kg/min)
Time frame: 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.
Time frame: 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).
Time frame: During the procedure