NCT06256068

Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol

Not yet recruiting Last updated 6 April 2025

What this trial tests

trial in Neoplasms in 300 participants. Not yet recruiting.

Timeline

1 June 2025

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	Medical University of Warsaw
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 June 2025
Primary completion	30 June 2026
Estimated completion	30 June 2026

Conditions studied

• Neoplasms — all drugs for Neoplasms →

Sponsor

Medical University of Warsaw

Who can join

Adults 8 to 18, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Determinants of physical activity level in pediatric oncological patients treated with cardiotoxic therapy - a study protocol.
   Haponiuk-Skwarlińska J, Gąsior JS, Albrecht K, Łaguna P, et al · · 2025 · PMID 40320516 · DOI 10.1186/s12887-025-05714-5