Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility Criteria 3 - Data Quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Feasibility Criteria 3 - Data Quality
时间窗: Throughout study completion, an average of 2 years
Number of evaluable examination data.
Feasibility Criteria 1 - Recruitment Rate
时间窗: 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
时间窗: Throughout study completion, an average of 2 years
Feedback questionnaire with multiple choice options and free text answers.
Feasibility Criteria 2 - Acceptance
时间窗: Throughout study completion, an average of 2 years
Number of finished and discontinued exercise stress echocardiographies.
Feasibility Criteria 4 - Practicability
时间窗: Throughout study completion, an average of 2 years
Difference between scheduled and required time frame for the single examination.
次要结局
- 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)
研究者
Sabine Kesting
Dr. rer. medic.
Technical University of Munich