Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-02 @ 2:24 AM
Study NCT ID:
NCT04320420
Status:
UNKNOWN
Last Update Posted:
2021-10-08
First Post:
2020-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)
Sponsor:
Weprom
Organization:
Study Overview
Official Title:
Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APA²
Brief Summary:
Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.
Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.
The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.
The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.
This is a feasibility study.
Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.
The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.
The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.
This is a feasibility study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02203-54 | OTHER | French Health Products Safety Agency | View |