Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment
NCT ID: NCT05261256
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
80 participants
OBSERVATIONAL
2022-02-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
\- Appropriate as matched pair with respect to age and gender
Exclusion Criteria
* 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.
10 Years
25 Years
ALL
Yes
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Technical University of Munich
OTHER
Responsible Party
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Sabine Kesting
Dr. rer. medic.
Principal Investigators
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Renate Oberhoffer-Fritz, Prof. Dr. med.
Role: STUDY_CHAIR
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM
Locations
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Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Munich, , Germany
Countries
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Other Identifiers
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German Heart Foundation
Identifier Type: -
Identifier Source: org_study_id