Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxi… (NCT06256068) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
300 participantsStarted 2025-06-01
Plain-language summary
Cancer treatment in children is generally effective, but unfortunately, it often comes with side effects-unwanted negative impacts. Some medications used in cancer treatment, while beneficial in treating the disease, can have harmful effects on the heart and reduce a child's ability to tolerate physical activities such as climbing stairs, walking fast, running, or exercising. Physical activity is crucial for the proper growth and development of children, as well as for their future health as adults. The heart plays a vital role in pumping blood throughout the body, and its proper function is key to a person's ability to engage in physical activity.
The goal of this study is to understand the factors that influence physical activity levels in children who have undergone cancer treatment with methods that may be harmful to the heart. The researchers aim to investigate how these treatments affect the physical activity levels of these children.
The main questions the study seeks to answer are:
Do children who have undergone cancer treatment involving heart-toxic methods show lower levels of daily physical activity compared to children treated with non-toxic methods?
Is the level of physical activity influenced by heart-toxic treatment, or by other factors such as exercise capacity (measured through physical tests like treadmill or standing bike tests), quality of life, lifestyle, social and demographic factors, body type, or knowledge and motivation related to the positive effects of physical activity?
Participants will:
Complete a questionnaire
Perform an exercise test on a treadmill or standing bike to measure exercise capacity
Take part in the ALPHA physical fitness test, which includes simple exercises like jumping and running
Be measured for height and weight
Undergo a hand-grip test using a hand dynamometer
Wear an activity tracker for 14 days
Have an echocardiogram (ultrasound of the heart)
Researchers will compare 150 children treated with heart-toxic methods for cancer to 150 children treated with non-toxic methods. The children will be between 8 and 18 years old and will be 1 to 5 years post-cancer treatment.
The researchers hope that identifying the factors affecting physical activity levels in children treated with heart-toxic methods may improve cancer therapies for children, reduce side effects, and ultimately lead to increased physical activity. This would help promote better growth and overall health for these children in the future.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. age 8-18 years,
. diagnosis of, and completed treatment for, cancer \>1 year and \<5 years ago,
. remission of the cancer,
. treatment involving use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation),
. at least 6 weeks since the last signs or symptoms of an infection,
. written consent signed by the parents/guardians and by patients aged ≥16 years. Control group
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical activity level measured by the accelerometer
. history of another cancer and its treatment with or without the use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation),
. significant physical disability or a muscosceletal disorder at the time of the enrollment (congenital or as a consequence of treatment, especially neurological complications and lower extremities conditions and amputation),
. excessive malaise (at the time of the enrollment),
. intellectual disability (on the level that disenables the participant from understanding and cooperation during the CPET procedure or ALPHA test),
. active acute inflammatory disease including the following: autoimmunological, neurological, pulmonological, endocrinological, cardiovascular, and gastrointestinal,
. platelet count \< 20 G/L,
. hemoglobin concentration \< 9g /dL,
. severe residual changes (protein loss syndrome, peritoneal, pericardial or pleural effusion, arrhythmia, metabolic disorders),