Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

NCT05383092 | Recruiting

• 1 other identifier: RC31/22/0061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Keywords

pediatric cancers; exercise; insulin sensibility; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Homeostasis Model Assessment of Insulin Resistance

  6 months

Study Arms (2)

Adapted physical activity Strong

EXPERIMENTAL

Other: Adapted Physical Activity Strong

Adapted physical activity Soft

ACTIVE COMPARATOR

Other: Adapted Physical Activity Strong

Interventions

Adapted Physical Activity Strong OTHER

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.

Adapted physical activity Soft; Adapted physical activity Strong

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

PASQUET Marlène

Toulouse, 31, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marlène PASQUET, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlène PASQUET, MD, PhD

CONTACT

05 34 55 86 08; pasquet.m@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized pilot study studying the parameters of two groups receiving physical activity management over a period of 6 months

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)