Cancer Clinical Trial
Context: Sport and physical activity during and after cancer treatment can improve fitness
and social inclusion in adults. In children, although early studies show interesting
results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children
following a physical training program showed a significant improvement in endurance, muscle
tone, overall self-esteem, sports skills and self-perceived strength. The investigators then
want to evaluate the health of a group of children during treat cancer that physical
activities adapted compared to children who did not practice.
Objective: Measuring the impact of physical activity program on health of children and
adolescents with cancer with improved physical, psychological health, social reintegration
and reduced time hospitalization.
Method and Design: The study plans to include 90 children from the pediatric hematology -
oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18
months.
This is a randomized controlled open trial open with a stratified distribution. Children
will be randomized between two arms - Arm A (Experimental - Immediate Program): the child
follows the physical activity program for a period of 18 months, as soon as his medical
condition permits. - Arm B (Control - Delayed Program): the child does not participate to
the program during the first 6 months, and he joins the delayed program late after 6 months.
Each child integrates the physical program for a period of one year.
Regardless of the randomization arm, the child performs the initial tests, the intermediate
tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be
performed at 3 and 9 months.
The physical activity program includes a minimum of 30 days of activities per 6 months
(4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.
The investigators aim at demonstrating a difference of 50 meters on the total walked
distance during the endurance test in the experimental group as compared to the control
group after 6 months of program.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | November 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 19 Years |
| Eligibility |
Inclusion Criteria: - Patient with malignant disease - Supported in service pediatric hematology-oncology child Timone hospital in Marseille. - Age = 5 years and = 19 years - No medical-cons to the practice of physical activity Exclusion Criteria: - Life expectancy less than 18 months. - Inability to comply with follow-up study for geographical, social or psychological. - Length of stay less than 18 months, for children living outside mainland - Not understanding of the French language - Prior Participation in physical activity program |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance publique hopitaux de marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program. | 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|