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Recruiting NCT05383092

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

No phase Interventional Pediatric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adapted Physical Activity Strong.
Who it may be relevant to
Registry conditions: Pediatric Cancer. Basic parameters: 5 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. In view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.

Detailed description

The protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. Evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. The physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. The sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. They will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. Inclusion lasts two years.

Interventions

  • Other Adapted Physical Activity Strong
    Children will practice physical activities combining aerobics and muscle strengthening. They will follow a 30-minute (for prepubescent children) or 60-minute (for pubescent children) Strong adapted physical activity session 2 to 3 times a week during hospitalization periods or by videoconference at home when they are not hospitalized.

Primary outcome measures

  • Insulin Sensitivity [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • age between 5 and 18 years old;
  • have a solid cancer or hematological disease;
  • be treated for the first time in pediatric oncology and hematology department;
  • have an estimated life expectancy at diagnosis of more than 6 months.

Exclusion criteria

  • present a physical and/or psychological impossibility to follow an adapted physical activity program;
  • have a pre-existing heart disease that is not suitable for adapted physical activities;
  • have a known type 1 diabetes
  • have an obesity defined by a body mass index greater than or equal to the International Obesity Task Force 25 threshold

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • PASQUET Marlène — Toulouse

Publications

  • Thomas J, Filleron T, Auriol F, Laurens C, Pasquet M. Study protocol of an early randomized intervention trial assessing the metabolic effects of two levels of exercise intensity in children undergoing cancer treatment: the APACIS study. BMC Cancer. 2025 May 9;25(1):850. doi: 10.1186/s12885-025-14235-4. PMID 40346598

Identifiers

NCT: NCT05383092 · RC31/22/0061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗