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Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol - Trial NCT06256068

Access comprehensive clinical trial information for NCT06256068 through Pure Global AI's free database. This phase not specified trial is sponsored by Medical University of Warsaw and is currently Not yet recruiting. The study focuses on Neoplasms. Target enrollment is 290 participants.

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NCT06256068
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Trial Details
ClinicalTrials.gov โ€ข NCT06256068
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Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol

Study Focus

Neoplasms

Observational

Sponsor & Location

Medical University of Warsaw

Timeline & Enrollment

N/A

Feb 05, 2024

Jun 30, 2026

290 participants

Primary Outcome

Physical activity level measured by the accelerometer

Summary

Cancer treatment in children is very effective, but unfortunately has side effects -
 unwanted, bad impact. Some drugs that are given during cancer treatment, in addition to their
 good effect, can affect the heart badly and can lower the physical activity tolerance, such
 as climbing stairs, fast walking, running, exercise. Physical activity is very important for
 the proper growth and development of children and future adults. Heart is an important organ
 pumping the blood around the body and its good function is one of the key determinants of
 physical activity level in humans.
 
 The goal of this study is to is to find what impacts physical activity level in children
 treated for cancer with treatment methods that may be toxic to the heart to learn about
 influence of this treatment on the physical activity level of these children.
 
 The main questions this study aims to answer are:
 
 - Do children after cancer treatment involving heart toxic treatment methods present lower
 level of daily physical activity in comparison to the children treated with different
 methods?
 
 - Is the level of physical activity related to the heart toxic treatment, or other such as
 exercise capacity (measured physical strength on the treadmill or standing bike),
 quality of life, lifestyle, social and demographic factors, body type as well as the
 knowledge about positive impact of physical activity, efficacy, and motivation to
 physical activity?
 
 Participants will:
 
 - fill in the questionnaire,
 
 - perform an exercise test on the treadmill or standing bike (to measure exercise
 capacity),
 
 - perform ALPHA test (physical fitness test) consisting of some simple exercise like
 jumping, running etc.,
 
 - be measured and weighted,
 
 - be measured by the hand-grip test with the hand dynamometer machine,
 
 - wear activity-tracker band for 14 days,
 
 - be examined by the ultrasound of the heart (echocardiography).
 
 Researchers will compare 144 children treated with heart toxic methods for cancer to 144
 children treated for cancer with non-toxic methods. The children will be aged 8-18 years old
 and will be 1-5 years after treatment for cancer.
 
 The researchers believe that finding what influences physical activity level in children
 after cancer treatment with heart toxic methods may
 
 - make the therapy for cancer in children better, with less side effects
 
 - by that, can cause increase in the physical activity and ensure better growth and health
 for these children in the future.

ICD-10 Classifications

Neoplasms
In situ neoplasms
Personal history of other neoplasms
Benign neoplasms
Malignant neoplasms

Data Source

ClinicalTrials.gov

NCT06256068

Non-Device Trial