Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
186
APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)
CHU Jean Minjoz
Besançon, France
NOT_YET_RECRUITINGClinique Victor Hugo / Centre Jean Bernard
Le Mans, France
RECRUITINGCHRU Nancy
Nancy, France
NOT_YET_RECRUITINGHôpital Privé du Confluent
Nantes, France
RECRUITINGCH Perpignan
Perpignan, France
RECRUITINGTo detect an absolute difference of 15% in event-free survival between the 2 groups
Event-free survival will be defined as the time between the date of inclusion and the date of the event or the date of the latest news if the patient is censored.
Time frame: 5 years
The compliance with the 72 sessions of APA
Number of sessions performed per patient per part of the program
Time frame: 6 months
The overall physical activity load per patient and per session
Evaluated according to the Foster method (duration of the session in minutes x perceived effort according to the modified Borg scale)
Time frame: 6 months
The overall survival
Time between the date of inclusion and the date of death if the patient is deceased or the date of the latest news if the patient is censored
Time frame: 5 years
The progression free survival
time between the inclusion date and the date of the first examination showing Progression of the disease or the date of death if the patient is deceased or the date of the latest news if the patient is censored
Time frame: 5 years
The progression-free survival after relapse and resumption of therapy
Time between the date of the start of re-treatment and the date of the first examination showing progression of the disease or the date of death if the patient has died or the date of the latest news if the patient is censored,
Time frame: 5 years
The complete and partial response rates
according to Lugano criteria
Time frame: 1 year
The prevalence of complications
Number of patients who presented complication in the numerator and the number of patients followed in the denominator
Time frame: 6 months
The incidence of sarcopenia during follow-up
by CT scan during follow-up will be evaluated by the number of patients with sarcopenia diagnosed during follow-up in the numerator and the number of patients followed in the denominator
Time frame: 2 years
The prevalence of nutritional disorders at diagnosis and at the end of treatment
The number of patients with a disorder of nutritional status in the numerator and the number of patients followed in the denominator,
Time frame: 6 months
The rate of endocrinopathies
Number of patients with endocrinopathy between the inclusion date and the study discharge date in the numerator and the number of patients followed in the denominator
Time frame: 6 months
The rate of second cancers
Number of patients who presented with a second cancer during the study
Time frame: 5 years
The rate of cardiovascular events
Number of patients with a cardiovascular event
Time frame: 5 years
The quality of life of patients
Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)
Time frame: 5 years
The fatigue of patient
Change from baseline of Multidimensional fatigue inventory score (higher score means worse outcome)
Time frame: 5 years
The depression of patient
Change from baseline of Geriatric depression scale (higher score means worse outcome)
Time frame: 5 years
The cost of hospitalizations
Hospitalizations will be quote (economic data) by medical information department of center
Time frame: 5 years
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