Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05261256
• Other study ID #: German Heart Foundation
• Status: Enrolling by invitation
• Start date: February 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
Germany	Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility Criteria 2 - Acceptance	Number of finished and discontinued exercise stress echocardiographies.	Throughout study completion, an average of 2 years
Primary	Feasibility Criteria 3 - Data Quality	Number of evaluable examination data.	Throughout study completion, an average of 2 years
Primary	Feasibility Criteria 4 - Practicability	Difference between scheduled and required time frame for the single examination.	Throughout study completion, an average of 2 years
Primary	Feasibility Criteria 5 - Participants' Feedback	Feedback questionnaire with multiple choice options and free text answers.	Throughout study completion, an average of 2 years
Secondary	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
Secondary	Analysis of Echocardiography Marker 1	Deformation Parameters in % (global longitudinal strain and circumferencial strain)	During the procedure
Secondary	Analysis of Echocardiography Marker 2	Ejection Fraction (EF) in %	During the procedure
Secondary	Analysis of Echocardiography Marker 3	M-Mode Parameter	During the procedure
Secondary	Analysis of Echocardiography Marker 4	Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter	During the procedure
Secondary	Analysis of Echocardiography Marker 5	Left ventricle end diastolic volume (LVEDV) in ml/m²	During the procedure
Secondary	Cardiorespiratory Fitness	Submaximal oxygen uptake VO2peak (ml/kg/min)	During the procedure
Secondary	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
Secondary	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