Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Pediatric Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80992
    • Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Criteria 1 - Recruitment Rate	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.	Throughout study completion, an average of 2 years
Feasibility Criteria 2 - Acceptance	Number of finished and discontinued exercise stress echocardiographies.	Throughout study completion, an average of 2 years
Feasibility Criteria 3 - Data Quality	Number of evaluable examination data.	Throughout study completion, an average of 2 years
Feasibility Criteria 4 - Practicability	Difference between scheduled and required time frame for the single examination.	Throughout study completion, an average of 2 years
Feasibility Criteria 5 - Participants' Feedback	Feedback questionnaire with multiple choice options and free text answers.	Throughout study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference Values of Healthy Peers	Assessment of reference values from age- and gender-matched healthy peers (matched pairs).	Throughout study completion, an average of 2 years
Analysis of Echocardiography Marker 1	Deformation Parameters in % (global longitudinal strain and circumferencial strain)	During the procedure
Analysis of Echocardiography Marker 2	Ejection Fraction (EF) in %	During the procedure
Analysis of Echocardiography Marker 3	M-Mode Parameter	During the procedure
Analysis of Echocardiography Marker 4	Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter	During the procedure
Analysis of Echocardiography Marker 5	Left ventricle end diastolic volume (LVEDV) in ml/m²	During the procedure
Cardiorespiratory Fitness	Submaximal oxygen uptake VO2peak (ml/kg/min)	During the procedure
Physical Activity Level post-therapy	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.	During the procedure
Physical Activity Level in Healthy Control Subjects	For healthy control subjects: Physical activity questionnaire from the KiGGS study (German Health Interview and Examination Survey for Children and Adolescents).	During the procedure

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Ludwig-Maximilians - University of Munich
• Investigators: Study Chair: Renate Oberhoffer-Fritz, Prof. Dr. med., Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Childhood cancer; Early detection; Stress echocardiography; Late effects; Cardiac impairments
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: German Heart Foundation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No