Cardiovascular Diseases, Pediatric Cancer
Conditions
Keywords
Childhood cancer, Cardiac impairments, Late effects, Early detection, Prevention, Stress echocardiography
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.
Interventions
DIAGNOSTIC_TESTExercise 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.
Sponsors
Technical University of Munich
Ludwig-Maximilians - University of Munich
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 2 - Acceptance | Throughout study completion, an average of 2 years | Number of finished and discontinued exercise stress echocardiographies. |
| Feasibility Criteria 3 - Data Quality | Throughout study completion, an average of 2 years | Number of evaluable examination data. |
| Feasibility Criteria 4 - Practicability | Throughout study completion, an average of 2 years | Difference between scheduled and required time frame for the single examination. |
| Feasibility Criteria 5 - Participants' Feedback | Throughout study completion, an average of 2 years | Feedback questionnaire with multiple choice options and free text answers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Analysis of Echocardiography Marker 1 | During the procedure | Deformation Parameters in % (global longitudinal strain and circumferencial strain) |
| Analysis of Echocardiography Marker 2 | During the procedure | Ejection Fraction (EF) in % |
| Analysis of Echocardiography Marker 3 | During the procedure | M-Mode Parameter |
| 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. |
| 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). |
Countries
Germany
Contacts
STUDY_CHAIRRenate Oberhoffer-Fritz, Prof. Dr. med.
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM
Outcome results
None listed