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NCT Number: NCT04670029

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

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Jean Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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),
  • 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)
  • Aged ≥ 65 years old,
  • Eligible for treatment with RCHOP, regardless of the IPI score adjusted for age,
  • Performance Status ≤ 2,
  • Patient affiliated to a social security scheme,
  • Patient who has given written consent before any specific procedure related to the study

Exclusion criteria

  • Any other type of lymphoma (T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma, etc.),
  • Cerebral or meningeal damage related to hemopathy,
  • Acquired or congenital motor or sensory deficit which does not allow the completion of APA sessions,
  • Uncontrolled arterial hypertension,
  • Disabling heart or respiratory failure not allowing the completion of APA sessions,
  • Disabling osteo-articular or muscular pathology,
  • LVEF <50%,
  • Patient having received 3 or more cycles of 1st line chemotherapy,
  • Pregnancy or breastfeeding,
  • Active viral infection: hepatitis B, C and HIV,
  • Persons deprived of their liberty or under guardianship
  • 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,
  • Patient who can't follow protocol for psychological, social, family or geographic reasons

Treatment and study plan

adapted physical activity

Other

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

Primary outcomes

  1. To detect an absolute difference of 15% in event-free survival between the 2 groups

    Time frame: 5 years

    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.

Secondary outcomes

  1. The compliance with the 72 sessions of APA

    Time frame: 6 months

    Number of sessions performed per patient per part of the program

  2. The overall physical activity load per patient and per session

    Time frame: 6 months

    Evaluated according to the Foster method (duration of the session in minutes x perceived effort according to the modified Borg scale)

  3. The overall survival

    Time frame: 5 years

    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

  4. The progression free survival

    Time frame: 5 years

    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. The progression-free survival after relapse and resumption of therapy

    Time frame: 5 years

    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,

  6. The complete and partial response rates

    Time frame: 1 year

    according to Lugano criteria

  7. The prevalence of complications

    Time frame: 6 months

    Number of patients who presented complication in the numerator and the number of patients followed in the denominator

  8. The incidence of sarcopenia during follow-up

    Time frame: 2 years

    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

  9. The prevalence of nutritional disorders at diagnosis and at the end of treatment

    Time frame: 6 months

    The number of patients with a disorder of nutritional status in the numerator and the number of patients followed in the denominator,

  10. The rate of endocrinopathies

    Time frame: 6 months

    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

  11. The rate of second cancers

    Time frame: 5 years

    Number of patients who presented with a second cancer during the study

  12. The rate of cardiovascular events

    Time frame: 5 years

    Number of patients with a cardiovascular event

  13. The quality of life of patients

    Time frame: 5 years

    Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)

  14. The fatigue of patient

    Time frame: 5 years

    Change from baseline of Multidimensional fatigue inventory score (higher score means worse outcome)

  15. The depression of patient

    Time frame: 5 years

    Change from baseline of Geriatric depression scale (higher score means worse outcome)

  16. The cost of hospitalizations

    Time frame: 5 years

    Hospitalizations will be quote (economic data) by medical information department of center

Study contacts

Contact information is provided by the study sponsor or research team.

Magali BALAVOINE

CONTACT

[email protected]

0241682940 ext. 0033

Sponsors and collaborators

Lead sponsor

Weprom

Other

Registry information

Official study title

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

Acronym: PHARAOM

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Dec 17, 2020
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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