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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06256068
• Other study ID #: KB/54/A2023
• Status: Not yet recruiting
• Start date: February 5, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Julia Haponiuk-Skwarlinska, MD
• Phone: 515400472
• Email: julia.haponiuk-skwarlinska[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 290
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

Study group:

• age 8-18 years,

• diagnosis 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, hae-mopoietic stem cell transplantation and radiotherapy (TBI or mediastinum irradiation),

• at least 6 weeks from the last signs or symptoms of an infection,

• written consent signed by the parents and patients aged =16 years.

Control group:

• the same as for the experimental group and,

• cancer treatment without use of anthracyclines, kinase inhibitors targeting BRC-ABL, haemopoietic stem cell transplantation and radiotherapy (TBI or mediastinum irradiation).

Exclusion Criteria:

• past history of cancer and its treatment with or without the use of anthracyclines, kinase inhibitors targeting BRC-ABL, haemopoietic stem cell transplantation and radiotherapy (TBI or mediastinum irradiation),

• acute infection,

• active acute inflammatory disease including: autoimmunological, neurological, pul-monological, endocrinological, cardiovascular, gastrointestinal,

• platelet count < 20 G/L,

• hemoglobin concentration < 9g /dL,

• severe residual changes (protein loss syndrome, peritoneal, pericardial or pleural effu-sion, arrhythmia, metabolic disorders),

• previously diagnosed congenital heart defects or other heart diseases (including cardi-omyopathy, heart failure, arrythmia),

• relapse of the cancer at the moment of the enrollment to the study,

• severe malnutrition <3 SD BMI weight-for-age,

• lack of consent,

• lack of patient cooperation.

Additional exclusion criteria to conduct cardiopulmonary exercise test (CPET):

• contraindications to CPET examination including chronic cardiovascular diseases or musculoskeletal system disorders,

• excessive malaise (1 year after the treatment for the study group and the control group 1),

• intellectual disability,

• musculoskeletal system impairment,

• chronic concomitant diseases, especially endocrinological, neurological, gastroin-testinal, pulmonological,

• lack of cooperation during the CPET.

Related Conditions & MeSH terms

• Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level measured by the accelerometer	Physical activity level measured by the accelerometer and the assessment of the WHO pediatric, age-adjusted physical activity norms achievement	14 days measurement for 1 individual
Secondary	Percentage of participants disqualified from CPET	Percentage of participants disqualified from cardio-pulmonary exercise test (CPET) examination - objective assessment of exercise capacity	Measured at the enrollment
Secondary	Exercise capacity measured in CPET	VO2max below 47mL/kg/min for boys and 42 mL/kg/min for girls will be defined as the exercise capacity alterations in cardio-pulmonary exercise test	Measured at the enrollment
Secondary	Physical function in the ALPHA test battery	defining of the physical function level as low, moderate or high according to the ALPHA test battery	Measured at the enrollment
Secondary	Cardiac function	GLS (Global longitudinal strain) below average for age as well as the normal systolic function will be defined as a LVDd (Left ventricle diastolic diameter) within the normal limit and EF (ejection fraction) 55% or more, as well as the comparison to the control group	Measured at the enrollment