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Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity (APACIS)

Primary Purpose

Pediatric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted Physical Activity Strong
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Cancer focused on measuring pediatric cancers, exercise, insulin sensibility, metabolic syndrome

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 5 and 18 years old;
  • have a solid cancer or hematological disease;
  • be treated for the first time in Purpan's 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

Sites / Locations

  • PASQUET MarlèneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adapted physical activity Strong

Adapted physical activity Soft

Arm Description

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Homeostasis Model Assessment of Insulin Resistance

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
September 20, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05383092
Brief Title
Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
Acronym
APACIS
Official Title
Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer
Keywords
pediatric cancers, exercise, insulin sensibility, metabolic syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized pilot study studying the parameters of two groups receiving physical activity management over a period of 6 months
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adapted physical activity Strong
Arm Type
Experimental
Arm Title
Adapted physical activity Soft
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Adapted Physical Activity Strong
Intervention Description
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 Measure Information:
Title
Insulin Sensitivity
Description
Homeostasis Model Assessment of Insulin Resistance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlène PASQUET, MD, PhD
Phone
05 34 55 86 08
Ext
33
Email
pasquet.m@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlène PASQUET, MD, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
PASQUET Marlène
City
Toulouse
ZIP/Postal Code
31
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène PASQUET, MD, PhD
Phone
0534558608
Email
pasquet.m@chu-toulouse.fr

12. IPD Sharing Statement

Learn more about this trial

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

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