Pediatric CancerAPACISNCT05383092
Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
A study testing Adapted Physical Activity Strong in people with Pediatric Cancer, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Adapted Physical Activity Strong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
PASQUET Marlène
Toulouse, 31
Marlène PASQUET, MD, PhD, 0534558608, pasquet.m@chu-toulouse.fr
About this study
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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Adapted Physical Activity Strong
- Keywords
- pediatric cancers, exercise, insulin sensibility, metabolic syndrome
- Medical subject headings
- Neoplasms, Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity StrongOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted physical activity Strong | Experimental | Not described Receives: Other: Adapted Physical Activity Strong |
| Adapted physical activity Soft | Active comparator | Not described Receives: Other: Adapted Physical Activity Strong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Homeostasis Model Assessment of Insulin Resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start11 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlène PASQUET, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383092
- Sponsor's protocol ID
- RC31/22/0061
- Acronym
- APACIS
- Status last verified
- Sep 2023
- First submitted
- 16 May 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40346598
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT05383092
- Acronym / sponsor ID
- APACIS / RC31/22/0061
- Conditions
- Pediatric Cancer
- Keywords
- pediatric cancers, exercise, insulin sensibility, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized pilot study studying the parameters of two groups receiving physical activity management over a period of 6 months
| Arm | Type | Receives |
|---|---|---|
| Adapted physical activity Strong | Experimental | Other: Adapted Physical Activity Strong |
| Adapted physical activity Soft | Active comparator | Other: Adapted Physical Activity Strong |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical Activity StrongChildren 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. | Other | Adapted physical activity Soft, Adapted physical activity Strong |
Primary outcome
Insulin Sensitivity
Time frame: 6 months
Homeostasis Model Assessment of Insulin Resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 40346598Thomas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlène PASQUET, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity Strong in people with Pediatric Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlène PASQUET, MD, PhD (05 34 55 86 08 ext. 33, pasquet.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.