Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

NCT05261256 | Unknown

• 1 other identifier: German Heart Foundation
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Pediatric Cancer

Keywords

Childhood cancer; Cardiac impairments; Late effects; Early detection; Prevention; Stress echocardiography

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Reference Values of Healthy Peers

  Throughout study completion, an average of 2 years

• Analysis of Echocardiography Marker 1

  During the procedure

• Analysis of Echocardiography Marker 2

  During the procedure

• Analysis of Echocardiography Marker 3

  During the procedure

• Analysis of Echocardiography Marker 4

  During the procedure

Study Arms (2)

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

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

Interventions

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.

Healthy control subjects; Participants treated for pediatric cancer

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Munich: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

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

Munich, 80992, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Neoplasms

Study Officials

• Renate Oberhoffer-Fritz, Prof. Dr. med.

  Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. medic.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: March 2, 2022
• Study Start: February 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)