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Completed

NCT Number: NCT05261256

Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

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.

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany

Munich, 80992, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise stress echocardiography

Diagnostic Test

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.

Primary outcomes

  1. Feasibility Criteria 1 - Recruitment Rate

    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.

  2. Feasibility Criteria 2 - Acceptance

    Time frame: Throughout study completion, an average of 2 years

    Number of finished and discontinued exercise stress echocardiographies.

  3. Feasibility Criteria 3 - Data Quality

    Time frame: Throughout study completion, an average of 2 years

    Number of evaluable examination data.

  4. Feasibility Criteria 4 - Practicability

    Time frame: Throughout study completion, an average of 2 years

    Difference between scheduled and required time frame for the single examination.

  5. Feasibility Criteria 5 - Participants' Feedback

    Time frame: Throughout study completion, an average of 2 years

    Feedback questionnaire with multiple choice options and free text answers.

Secondary outcomes

  1. Reference Values of Healthy Peers

    Time frame: Throughout study completion, an average of 2 years

    Assessment of reference values from age- and gender-matched healthy peers (matched pairs).

  2. Analysis of Echocardiography Marker 1

    Time frame: During the procedure

    Deformation Parameters in % (global longitudinal strain and circumferencial strain)

  3. Analysis of Echocardiography Marker 2

    Time frame: During the procedure

    Ejection Fraction (EF) in %

  4. Analysis of Echocardiography Marker 3

    Time frame: During the procedure

    M-Mode Parameter

  5. Analysis of Echocardiography Marker 4

    Time frame: During the procedure

    Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter

  6. Analysis of Echocardiography Marker 5

    Time frame: During the procedure

    Left ventricle end diastolic volume (LVEDV) in ml/m²

  7. Cardiorespiratory Fitness

    Time frame: During the procedure

    Submaximal oxygen uptake VO2peak (ml/kg/min)

  8. Physical Activity Level post-therapy

    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.

  9. Physical Activity Level in Healthy Control Subjects

    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).

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Aug 19, 2026

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.

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