NeoplasmsNCT06256068
Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
An observational study of Neoplasms, run by Medical University of Warsaw.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Neoplasms
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study group will consist of 144 children >1 year and <5 years from a cancer treatment completion involving car-diotoxicity risk factors and are now in the follow-up observation at the outpatient clinic. The control group is going to involve 144 children who are >1 year and <5 years from a cancer treatment completion without cardiotoxicity risk factors and are now in the follow-up observation. The sample size was calculated for an unmatched case-control study with the input parameters of a 2-sided confidence level of 0.95, power 80%, ratio of controls to cases 1:1, and odds an ratio of 2.0. The sample size calculation by Fleiss with CC method showed 144 participants for each group. Considering a dropout rate of 10%, the total sample size required is 300.
Study group 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
- the same as for the experimental group and, b. cancer treatment without use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation).
Both groups Exclusion criteria
- 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),
- previously diagnosed congenital heart defects or other heart diseases (including cardiomyopathy, heart failure, arrythmia),
- relapse of the cancer at the time of enrollment to the study,
- severe malnutrition <3 standard deviation (SD) body mass index (BMI) weight for age,
- chronic concomitant diseases that could affect the CPET outcome, especially endocrinological, neurological, gastrointestinal, and pulmonological*,
- lack of patient cooperation.
- endocrinological - decompensated thyroid disease, decompensated diabetes with hypoglycemia; neurological - conditions disabling the CPET performance due to musculoskeletal system alteration, uncontrolled epilepsy, myopathy; gastrointestinal - marasmus, decompensated hepatic insufficiency; pulmonological - asthma, interstitial lung disease, post-infection bronchiolitis obliterans (PIBO) - additionally, pulmonary embolism, lower extremity phlebitis, kidney failure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Neoplasms
- Keywords
- exercise capacity, physical activity, cardiotoxicity, childhood cancer, pediatric oncology
- Medical subject headings
- Neoplasms, Motor Activity, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Study Group: 150 children aged 1 to 5 years, who have completed cancer treatment involving cardiotoxicity risk factors, are now being monitored in follow-up observations. The participants' examination will include: An exercise capacity test (CPET) to assess exercise capacity An extended ALPHA (Assessing Levels of Physical Activity) health-related fitness test battery to evaluate physical function Echocardiography to assess cardiac function Questionnaires, including the Pediatric Quality of Life Inventory (PedsQL) to measure quality of life, the Physical Activity and Leisure Motivation Scale (PALMS) to assess motivation for physical activity, and an original questionnaire to evaluate lifestyle, socio-demographic factors, self-efficacy, and anthropometric factors Use of an ActiGraph GT3X Accelerometer-a wearable device attached to an elastic belt-to monitor physical activity levels for 14 days | |
| control group | Control Group: 150 children aged 1 to 5 years, who have completed cancer treatment without cardiotoxicity risk factors, are also under follow-up observation. The examination for this group will include: An exercise capacity test (CPET) to assess exercise capacity An extended ALPHA health-related fitness test battery to evaluate physical function Echocardiography to assess cardiac function Questionnaires, including the Pediatric Quality of Life Inventory (PedsQL) to measure quality of life, the Physical Activity and Leisure Motivation Scale (PALMS) to assess motivation for physical activity, and an original questionnaire to evaluate lifestyle, socio-demographic factors, self-efficacy, and anthropometric factors Use of an ActiGraph GT3X Accelerometer to measure physical activity levels for 14 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level measured by the accelerometer
The primary outcome of interest is the PA level measured by the accelerometer and the assessment of the World Health Organization (WHO) pediatric, age-adjusted PA achievement norms.
Measured: 14 days measurement for 1 individual
Secondary outcomes (4)
Percentage of participants disqualified from CPET
Percentage of participants disqualified from CPET examination - secondary outcome is the assessment of the proportion of eligible pediatric oncology patients for CPET examination as well as the reasons and characteristics of the patients that were excluded from CPET examination,
Measured: Measured at the enrollment
Exercise capacity measured in CPET
Exercise capacity measured in CPET - maximal/peak oxygen consumption (VO2max/peak) below 47 mL/kg/min for boys and 42 mL/kg/min for girls will be defined as the EC alterations - secondary outcome is the maximal/peak oxygen consumption (VO2max/peak) measurement and defining the EC among the participants,
Measured: Measured at the enrollment
Physical function in the ALPHA test battery
Assessment of the fitness in the extended ALPHA (Assessing Levels of Physical Activity) health-related fitness test battery - defining the fitness level as low, moderate, or high (33, 34) - secondary outcome is the assessment of the physical fitness among the study group in the extended ALPHA test and defining its level,
Measured: Measured at the enrollment
Cardiac function
In cardiological assessment: global longitudinal strain (GLS), global radial strain (GRS), and global circumferential strain (GCS) below average for age, left ventricle diastolic diameter (LVDd) exceeding the normal limit, and ejection fraction (EF) 55% or less will be defined as the lowered systolic function, as well as in the comparison to the control groups - secondary outcome is the contractile function assessment of the heart among the study group and in comparison to the control group.
Measured: Measured at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Haponiuk-Skwarlińska, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256068
- Sponsor's protocol ID
- KB/54/A2023
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data (individual participant data (IPD) collected in this study) supporting the conclusions of this article will be made available by the authors, without undue reservation.
Publications
Haponiuk-Skwarlinska J, Gasior JS, Albrecht K, Laguna P, Werner B. Determinants of physical activity level in pediatric oncological patients treated with cardiotoxic therapy - a study protocol. BMC Pediatr. 2025 May 5;25(1):355. doi: 10.1186/s12887-025-05714-5.
PubMed 40320516
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
- ClinicalTrials.gov ID
- NCT06256068
- Acronym / sponsor ID
- KB/54/A2023
- Conditions
- Neoplasms
- Keywords
- exercise capacity, physical activity, cardiotoxicity, childhood cancer, pediatric oncology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Study Group: 150 children aged 1 to 5 years, who have completed cancer treatment involving cardiotoxicity risk factors, are now being monitored in follow-up observations. The participants' examination will include: An exercise capacity test (CPET) to assess exercise capacity An extended ALPHA (Assessing Levels of Physical Activity) health-related fitness test battery to evaluate physical function Echocardiography to assess cardiac function Questionnaires, including the Pediatric Quality of Life Inventory (PedsQL) to measure quality of life, the Physical Activity and Leisure Motivation Scale (PALMS) to assess motivation for physical activity, and an original questionnaire to evaluate lifestyle, socio-demographic factors, self-efficacy, and anthropometric factors Use of an ActiGraph GT3X Accelerometer-a wearable device attached to an elastic belt-to monitor physical activity levels for 14 days |
| control group | – | –Control Group: 150 children aged 1 to 5 years, who have completed cancer treatment without cardiotoxicity risk factors, are also under follow-up observation. The examination for this group will include: An exercise capacity test (CPET) to assess exercise capacity An extended ALPHA health-related fitness test battery to evaluate physical function Echocardiography to assess cardiac function Questionnaires, including the Pediatric Quality of Life Inventory (PedsQL) to measure quality of life, the Physical Activity and Leisure Motivation Scale (PALMS) to assess motivation for physical activity, and an original questionnaire to evaluate lifestyle, socio-demographic factors, self-efficacy, and anthropometric factors Use of an ActiGraph GT3X Accelerometer to measure physical activity levels for 14 days. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study group will consist of 144 children >1 year and <5 years from a cancer treatment completion involving car-diotoxicity risk factors and are now in the follow-up observation at the outpatient clinic. The control group is going to involve 144 children who are >1 year and <5 years from a cancer treatment completion without cardiotoxicity risk factors and are now in the follow-up observation. The sample size was calculated for an unmatched case-control study with the input parameters of a 2-sided confidence level of 0.95, power 80%, ratio of controls to cases 1:1, and odds an ratio of 2.0. The sample size calculation by Fleiss with CC method showed 144 participants for each group. Considering a dropout rate of 10%, the total sample size required is 300.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity level measured by the accelerometer
Time frame: 14 days measurement for 1 individual
The primary outcome of interest is the PA level measured by the accelerometer and the assessment of the World Health Organization (WHO) pediatric, age-adjusted PA achievement norms.
4 secondary outcomes
Percentage of participants disqualified from CPET
Time frame: Measured at the enrollment
Exercise capacity measured in CPET
Time frame: Measured at the enrollment
Physical function in the ALPHA test battery
Time frame: Measured at the enrollment
Cardiac function
Time frame: Measured at the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 40320516Haponiuk-Skwarlinska J, Gasior JS, Albrecht K, Laguna P, Werner B. Determinants of physical activity level in pediatric oncological patients treated with cardiotoxic therapy - a study protocol. BMC Pediatr. 2025 May 5;25(1):355. doi: 10.1186/s12887-025-05714-5.
- Individual participant dataSharing planned: No. The raw data (individual participant data (IPD) collected in this study) supporting the conclusions of this article will be made available by the authors, without undue reservation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Medical University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Haponiuk-Skwarlińska, MD (515400472 ext. 0048, julia.haponiuk-skwarlinska@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level measured by the accelerometer (time frame: 14 days measurement for 1 individual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.