Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04331483
Other study ID # EVAADE
Secondary ID ET 18-184
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 8, 2018
Est. completion date September 2023

Study information

Verified date February 2022
Source Centre Leon Berard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To date, allogeneic haematopoietic stem cell transplantation (aHSCT) is the only curative treatment for many paediatric and young adult haematological pathologies (acute leukaemia, myelodysplastic syndromes, haemoglobinopathies, bone marrow aplasia, severe combined immunodeficiency). Despite the major therapeutic progress made over the last 50 years, particularly in terms of supportive care, post-transplant morbidity and mortality remains high. Infectious complications, whose incidence varies between 30 and 60%, are the first cause of mortality in the immediate post-transplant period. In order to protect the patient from the occurrence of severe infectious episodes, aHSCTmust be performed in a highly protected environment (positive pressure chambers). This has implications for the experience and impact of hospitalization on the patient and family. This is particularly true in paediatrics, whether in children, adolescents or young adults, where it is not only the patient's quality of life that is at stake, but also their emotional and psychomotor development. In these patients, prolonged hospitalization (at least 6 weeks) in a sterile room will be responsible for physical deconditioning accompanied by a decrease in muscle mass, itself concomitant with undernutrition, and an increase in sedentary lifestyle. This prolonged hospitalisation in a sterile room, associated with myeloablative treatments, is therefore the cause of social isolation of patients, but it is also often synonymous with physical inactivity leading to a rapid decrease in physical condition, quality of life and an increase in fatigue. Today, the benefits of physical activity (PA) during and after cancer treatment have been widely demonstrated. The objective is to evaluate the feasibility of an adapted physical activity program during the isolation phase for achieving aHSCT in children, adolescents and young adults. This is a prospective, interventional, monocentric cohort study conducted at the Institute of Paediatric Haematology and Oncology in Lyon. The intervention will take place during the isolation phase and consists of an adapted physical activity (APA) program defined at inclusion, integrating supervised sessions with an APA teacher, as well as autonomous sessions. The program is individualized according to age, aerobic capacity, and PA preferences. Sessions are also tailored to the biological, psychological, and social parameters of patients. The total duration of the intervention is 3 months. To date, no PA studies have been performed in patients under 21 years of age requiring aGCSH during the sterile isolation phase. EVAADE will therefore be the first study in this population to offer an innovative procedure with a connected device.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 21 Years
Eligibility Inclusion Criteria: - 8 years = Age = 21 years - Size more or equal to 110 cm. - Histologically or cytologically confirmed malignant or non-malignant haemopathy - Indication for hematopoietic stem cell allograft. - Hospitalization in a protected room at IHOP/DAJAC. - Certificate of no contraindication to the practice of an APA, issued by the oncologist or attending physician. - Having available in the sterile room a smartphone (iPhone 5S version for Apple/version 5 under Android at least) or a tablet (for the realization of the connected challenges) during the whole hospitalization period. - Written consent signed and dated by the patient or the parents of minor patients with the acceptance of the minor. Exclusion Criteria: - Severe Heart Disease and Uncontrolled Cardiovascular Disease

Study Design


Intervention

Other:
Physical activity program
Supervised sessions of at least 15 minutes 4 times a Week combined with unsupervised sessions. The supervised activities include moderate-intensity aerobic activities (exercise bike), muscle strengthening (dumbbells, elastic bands, medicine balls) and playful situations (ball games, cooperative games, body expression games). Each patient can also do unsupervised sessions, autonomously, on the bike thanks to a smartphone application developed by the Kiplin company, with challenges to be carried out by teams of 2 to 5 people (team including several patients, possibility to include relatives) over periods of 1 to 3 weeks per challenge.

Locations

Country Name City State
France Institut d'Hématologie et d'Oncologie Pédiatrique Lyon

Sponsors (1)

Lead Sponsor Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Observance to the physical activity program achieved/non-achieved (achived meaning the patient attended at least one session of 15 minutes weekly during the whole program weekly from baseline to 3 months
Secondary Impact of the physical activity program on weight weight in kgs Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on waist circumference assessed in cm Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on hip circumference assessed in cm Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on abdominal circumference assessed in cm Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on body mass index weight/(size)2 Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on endurance capacity Harvard step test Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on muscle strength Dynamometer Baseline, 1 month and 3 months
Secondary Impact of the physical activity program on fatigue Visual analogic scale from 0 to 10 Baseline, 1 month and 3 months
Secondary Self-efficacy feeling HAPA questionnaire 3 months
Secondary Motivation towards physical activity BREQ questionnaire Baseline, 1 month and 3 months
Secondary Impact of the PA program on metabolic syndrome Lipid check-up Baseline and 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Terminated NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Phase 3
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Recruiting NCT04701229 - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended NCT04485065 - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS Phase 1
Recruiting NCT04174547 - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Completed NCT02508870 - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes Phase 1
Completed NCT04543305 - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies Phase 1
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Recruiting NCT05365035 - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Phase 2
Recruiting NCT06008405 - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1