Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Technical University of Munich
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Feasibility Criteria 3 - Data Quality
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sabine Kesting
Dr. rer. medic.
Technical University of Munich
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Feasibility Criteria 3 - Data Quality
Time Frame: Throughout study completion, an average of 2 years
Number of evaluable examination data.
Feasibility Criteria 1 - Recruitment Rate
Time Frame: Throughout study completion, an average of 2 years
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.
Feasibility Criteria 5 - Participants' Feedback
Time Frame: Throughout study completion, an average of 2 years
Feedback questionnaire with multiple choice options and free text answers.
Feasibility Criteria 2 - Acceptance
Time Frame: Throughout study completion, an average of 2 years
Number of finished and discontinued exercise stress echocardiographies.
Feasibility Criteria 4 - Practicability
Time Frame: Throughout study completion, an average of 2 years
Difference between scheduled and required time frame for the single examination.
Secondary Outcomes
- Analysis of Echocardiography Marker 2(During the procedure)
- Reference Values of Healthy Peers(Throughout study completion, an average of 2 years)
- Physical Activity Level in Healthy Control Subjects(During the procedure)
- Analysis of Echocardiography Marker 1(During the procedure)
- Analysis of Echocardiography Marker 3(During the procedure)
- Analysis of Echocardiography Marker 4(During the procedure)
- Analysis of Echocardiography Marker 5(During the procedure)
- Cardiorespiratory Fitness(During the procedure)
- Physical Activity Level post-therapy(During the procedure)