Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05379738
Other study ID # 21-PP-12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2022
Est. completion date April 10, 2028

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Nice
Contact SOLDATI Alizée
Phone 04 92 03 96 27
Email soldati.a@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is a study about adaptated physical activity for patients receiving a stem cell transplantation. They will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date April 10, 2028
Est. primary completion date December 10, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : - Patient aged 18 or more - Patient with social security - Patient who accept the study and sign the consent form - Patient programmed for an allogenic stem cell transplantation Non inclusion criteria : - Patients with a guardianship - Patients with a significant additional physic or mental disease Exclusion criteria - Patients who did not receive an allogeniac stem cell transplantation - Patients still hospitalized between day 30 and day 100 after stem cell transplantation - Patients who finally refuses the study - Patients who develop a physical or mental incapacity to practice physical activity

Study Design


Intervention

Other:
6 sessions of adapted physical activity after stem cell transplant
physical assessement before and after stem cell transplant: weight loss brachial muscle circumference grip strength evaluation short physical battery test psychometric assessment before and after stem cell transplant: quality of life questionary physical activities questionary

Locations

Country Name City State
France CHU NICE, hopital ARCHET 1, hématologie Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight loss Body weight n in kilograms before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Primary weight loss Calculation of the percent of body weight loss between the " before stem cell transplantation evaluation " and each evaluation after stem cell transplantation and after adaptated physical activity sessions. before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Secondary patient's ability to attend the classes number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility 3 months after stem cell transplantation
Secondary body mass index Measure of weight and height to evaluate the nutriotional status of a patient before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Secondary brachial muscle circumference evaluation in centimeters of the brachial circumference to evaluate the evolution of the muscle circumference after stem cell transplantation and adaptated physical activity compared to the evaluation before stem cell transplantation. Using a measuring tape before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Secondary grip strength evaluation it is a measure of muscular strength before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Secondary short physical battery test it is a series of 3 physical tests to evaluate mobility the first test is a balance test (4 points), the second test is an evaluation of a walking speed (4 points) and the third test is a Chair rise test (4 points) The global test is on 12 points (12 is the better score) before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Secondary Quality of Life Questionary C30 (QLQ-C30) it is a score to evaluate the quality of life of patients facing illness The subscales scores are transformed to a 0 to 100 scale, with higher score on functionnal scales indicating better function and higher scores on sumptom scales indicating worse symptoms before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Secondary in house developped physical activities questionary it is a questionnary created especially for this study to evaluate on each step the capacity of each patient to maintain physical activities (social activities, autonomy at home for cooking and hygiene care, autonomy for transport to go to hospital appointments) before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
See also
  Status Clinical Trial Phase
Terminated NCT03978312 - Nutrition Health Literacy of Cancer Patients and Their Support Networks.
Recruiting NCT03750994 - Economic Evaluation of Innovative Molecular Analyses in Onco-haematology
Recruiting NCT04397705 - Remote Monitoring of Cancer Patients With Suspected Covid-19 Phase 1
Recruiting NCT05678621 - Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension Phase 2/Phase 3
Recruiting NCT05203809 - Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
Active, not recruiting NCT03146468 - Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation Phase 2
Recruiting NCT05298930 - Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation N/A
Not yet recruiting NCT06395220 - Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation
Recruiting NCT05786716 - DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Teenage/Young Adult and Paediatric Patients With Cancers With HER2 Amplification or Activating Mutations Phase 2/Phase 3
Not yet recruiting NCT04673305 - Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies N/A
Recruiting NCT05768178 - DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers. Phase 2/Phase 3
Recruiting NCT05722886 - DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol Phase 2/Phase 3
Completed NCT03855969 - Central Venous Access Device Removal in Cancer Patients
Recruiting NCT04174053 - Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units N/A
Recruiting NCT05770544 - DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers. Phase 2/Phase 3
Completed NCT04236063 - Rehabilitation Needs of the Malaysian Haematological Cancer Survivors
Recruiting NCT05695638 - Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment
Recruiting NCT04298892 - Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
Withdrawn NCT03688789 - Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology N/A
Withdrawn NCT04331483 - A Study to Assess a Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts N/A