Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Munich, 80992, Germany
NCT Number: NCT05261256
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.
Looking for future studies?
Notify Me10 year–25 year
All sexes
Observational
Munich, 80992, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for all participants:
Additional inclusion criteria for participants following cancer treatment:
Additional inclusion criteria for healthy control subjects:
Exclusion criteria
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 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.
Time frame: 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.
Time frame: Throughout study completion, an average of 2 years
Number of finished and discontinued exercise stress echocardiographies.
Time frame: Throughout study completion, an average of 2 years
Number of evaluable examination data.
Time frame: Throughout study completion, an average of 2 years
Difference between scheduled and required time frame for the single examination.
Time frame: Throughout study completion, an average of 2 years
Feedback questionnaire with multiple choice options and free text answers.
Time frame: Throughout study completion, an average of 2 years
Assessment of reference values from age- and gender-matched healthy peers (matched pairs).
Time frame: During the procedure
Deformation Parameters in % (global longitudinal strain and circumferencial strain)
Time frame: During the procedure
Ejection Fraction (EF) in %
Time frame: During the procedure
M-Mode Parameter
Time frame: During the procedure
Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter
Time frame: During the procedure
Left ventricle end diastolic volume (LVEDV) in ml/m²
Time frame: During the procedure
Submaximal oxygen uptake VO2peak (ml/kg/min)
Time frame: 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.
Time frame: During the procedure
For healthy control subjects: Physical activity questionnaire from the KiGGS study (German Health Interview and Examination Survey for Children and Adolescents).
Technical University of Munich
Other
Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06278883
Body Temperature Changes, Cancer
Jacksonville, Florida, United States
View Trial DetailsNCT06671704
Cancer, Cardiovascular Diseases
Minneapolis, Minnesota, United States
View Trial DetailsNCT05869604
Behavior, Cancer
Durham, North Carolina, United States
View Trial DetailsNCT04657120
Cancer, Cardiovascular Diseases
Antwerp, Belgium
View Trial Details