Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

Sponsor

Technische Universität München (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05261256

Collaborator

Ludwig-Maximilians - University of Munich (Other)

Enrollment

Location

22.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Pediatric Cancer	Diagnostic Test: Exercise stress echocardiography

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants treated for pediatric cancer 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 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.
Healthy control subjects 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 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.

Arm

Intervention/Treatment

Participants treated for pediatric cancer

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

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.

Healthy control subjects

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

Outcome Measures

Primary Outcome Measures

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 [During the procedure]
Number of evaluable examination data.
Feasibility Criteria 4 - Practicability [During the procedure]
Difference between scheduled and required time frame for the single examination.
Feasibility Criteria 5 - Participants' Feedback [During the procedure]
Feedback questionnaire with multiple choice options and free text answers.

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

All

Accepts 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.