Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670029
Status:
RECRUITING
Last Update Posted:
2021-10-08
First Post:
2020-12-09
Brief Title:
Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
Sponsor:
Weprom
Organization:
Weprom
Study Overview
Official Title:
Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
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:
PHARAOM
Brief Summary:
Diffuse large B cell lymphoma is the most common histology of non-Hodgkins malignant lymphomas 31 of lymphomas with an incidence of between 15 and 20 new cases per year per 100000 inhabitants in France The median age is 65 and a third of patients are over 75 years old 60 of patients are cured after a standard regimen of chemotherapy with RCHOP 40 of patients will however relapse No other regimen has shown improvement in overall survival but poor prognosis factors have been identified Beyond these factors other prognostic factors can impact overall and progression-free survival sarcopenia nutritional status disorders 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 has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers breast colon prostate It is less obvious in hematology in view of studies published on adapted physical activity Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology
Sarcopenia is an often-underestimated event and is associated with older age co-morbidities increased infectious complications and early mortality
Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact
The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15 compared to the standard arm
The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers breast colon prostate It is less obvious in hematology in view of studies published on adapted physical activity Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology
Sarcopenia is an often-underestimated event and is associated with older age co-morbidities increased infectious complications and early mortality
Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact
The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15 compared to the standard arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02248-49 | OTHER | French Health Products Safety Agency | None |