Clinical trial NCT05261256: Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment
Official title: Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
Pediatric Cancer
Keywords: Childhood cancer
Cardiac impairments
Late effects
Early detection
Prevention
Stress echocardiography
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2022-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of pediatric cancer will be recruited during appointments in follow-up care at two departments for pediatric cancer in Munich.

Healthy peers will be recruited within social environment of participants with a history of cancer (siblings, close friends) and within schools and sport clubs.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Criteria 1 - Recruitment Rate
timeFrame: Throughout study completion, an average of 2 years
measure: Feasibility Criteria 2 - Acceptance
timeFrame: Throughout study completion, an average of 2 years
measure: Feasibility Criteria 3 - Data Quality
timeFrame: Throughout study completion, an average of 2 years
measure: Feasibility Criteria 4 - Practicability
timeFrame: Throughout study completion, an average of 2 years
measure: Feasibility Criteria 5 - Participants' Feedback
timeFrame: Throughout study completion, an average of 2 years
Secondary outcomes:
measure: Reference Values of Healthy Peers
timeFrame: Throughout study completion, an average of 2 years
measure: Analysis of Echocardiography Marker 1
timeFrame: During the procedure
measure: Analysis of Echocardiography Marker 2
timeFrame: During the procedure
measure: Analysis of Echocardiography Marker 3
timeFrame: During the procedure
measure: Analysis of Echocardiography Marker 4
timeFrame: During the procedure
measure: Analysis of Echocardiography Marker 5
timeFrame: During the procedure
measure: Cardiorespiratory Fitness
timeFrame: During the procedure
measure: Physical Activity Level post-therapy
timeFrame: During the procedure
measure: Physical Activity Level in Healthy Control Subjects
timeFrame: During the procedure
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Study officials:
affiliation: Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM
name: Renate Oberhoffer-Fritz, Prof. Dr. med.
role: STUDY_CHAIR
References: