Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

Pediatric Cancer Clinical Trial

— APACIS  

Official title:

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383092
• Other study ID #: RC31/22/0061
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Toulouse
• Contact: Marlène PASQUET, MD, PhD
• Phone: 05 34 55 86 08
• Email: pasquet.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
France	PASQUET Marlène	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Homeostasis Model Assessment of Insulin Resistance	6 months