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

Diffuse Large B Cell Lymphoma Clinical Trial

— PHARAOM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670029
• Other study ID #: WP-2020-03
• Secondary ID: 2019-A02248-49
• Status: Recruiting
• Phase: Phase 3
• Start date: September 8, 2021
• Est. completion date: February 2029

Study information

• Verified date: April 2021
• Source: Weprom
• Contact: Magali BALAVOINE
• Phone: 0241682940
• Email: m.balavoine[@]weprom.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: February 2029
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patient with diffuse large-cell B lymphoma regardless of the WHO 2016 classification subtype, or low-grade B lymphoma immediately transformed into high-grade B lymphoma (follicular lymphoma of the marginal zone, MALT, lymphocytic, lympho-plasma cells),

2. Treatment naïve or having benefited from 2 cycles of chemotherapy (prephase or COP and cycle n ° 1 of RCHOP) if Performance Status> 3 linked to hemopathy and reversible (= 2)

3. Aged = 65 years old,

4. Eligible for treatment with RCHOP, regardless of the IPI score adjusted for age,

5. Performance Status = 2,

6. Patient affiliated to a social security scheme,

7. Patient who has given written consent before any specific procedure related to the study

Exclusion Criteria:

1. Any other type of lymphoma (T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma, etc.),

2. Cerebral or meningeal damage related to hemopathy,

3. Acquired or congenital motor or sensory deficit which does not allow the completion of APA sessions,

4. Uncontrolled arterial hypertension,

5. Disabling heart or respiratory failure not allowing the completion of APA sessions,

6. Disabling osteo-articular or muscular pathology,

7. LVEF <50%,

8. Patient having received 3 or more cycles of 1st line chemotherapy,

9. Pregnancy or breastfeeding,

10. Active viral infection: hepatitis B, C and HIV,

11. Persons deprived of their liberty or under guardianship

12. Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,

13. Patient who can't follow protocol for psychological, social, family or geographic reasons

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• Adapted 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

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Weprom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To 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.	5 years
Secondary	The compliance with the 72 sessions of APA	Number of sessions performed per patient per part of the program	6 months
Secondary	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)	6 months
Secondary	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	5 years
Secondary	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	5 years
Secondary	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,	5 years
Secondary	The complete and partial response rates	according to Lugano criteria	1 year
Secondary	The prevalence of complications	Number of patients who presented complication in the numerator and the number of patients followed in the denominator	6 months
Secondary	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	2 years
Secondary	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,	6 months
Secondary	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	6 months
Secondary	The rate of second cancers	Number of patients who presented with a second cancer during the study	5 years
Secondary	The rate of cardiovascular events	Number of patients with a cardiovascular event	5 years
Secondary	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)	5 years
Secondary	The fatigue of patient	Change from baseline of Multidimensional fatigue inventory score (higher score means worse outcome)	5 years
Secondary	The depression of patient	Change from baseline of Geriatric depression scale (higher score means worse outcome)	5 years
Secondary	The cost of hospitalizations	Hospitalizations will be quote (economic data) by medical information department of center	5 years