RecruitingPhase 3NCT04670029

Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line


Sponsor

Weprom

Enrollment

186 participants

Start Date

Sep 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an adapted physical activity (APA) program — supervised exercise and movement therapy — can help elderly patients with aggressive B-cell lymphoma (a type of blood cancer) live longer without their cancer progressing when they are also receiving standard first-line chemotherapy (R-CHOP). **You may be eligible if you:** - Have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or a related aggressive lymphoma - Are 65 years of age or older - Are eligible to receive R-CHOP chemotherapy, regardless of your risk score - Are in good enough functional health (performance status 0–2, or higher if it is reversible due to the lymphoma itself) **You may NOT be eligible if you:** - Have already received more than two cycles of prior chemotherapy (beyond an initial prephase) - Have physical limitations that prevent participation in an exercise program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAdapted physical activity

APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)


Locations(5)

CHU Jean Minjoz

Besançon, France

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, France

CHRU Nancy

Nancy, France

Hôpital Privé du Confluent

Nantes, France

CH Perpignan

Perpignan, France

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NCT04670029


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