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NCT Number: NCT06890091

Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma

The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. "According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken". Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: "Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?"

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Key information

Conditions

Fatigue Symptom Adverse Events Chimeric Antigen Receptor T-cell Therapy Fatigue Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (age> 18year old)
  • Person hospitalised for treatment with CAR-T Cells for non-Hodgkin's lymphoma.
  • Person able to understand and read the French language.

Exclusion criteria

  • Patient under legal protection
  • Opposition to research

Treatment and study plan

Fatigue assessment

Other

Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale

Primary outcomes

  1. Fatigue score

    Time frame: At day 30

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    30 days after CAR-T cell injection

Secondary outcomes

  1. Fatigue score

    Time frame: At inclusion

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    5 days before CAR-T cells injection

  2. Fatigue score

    Time frame: At day 2

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  3. Fatigue score

    Time frame: At day 10

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  4. Fatigue score

    Time frame: At day 21

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  5. Physical Fatigue subscore

    Time frame: At inclusion

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    5 days before CAR-T cells injection

  6. Physical Fatigue subscore

    Time frame: At day 2

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  7. Physical Fatigue subscore

    Time frame: At day 10

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    10 days after CAR-T cells injection

  8. Physical Fatigue subscore

    Time frame: At day 21

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    21 days after CAR-T cells injection

  9. Physical Fatigue subscore

    Time frame: At day 30

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    30 days after CAR-T cells injection

  10. Cognitive Fatigue subscore

    Time frame: At inclusion

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    5 days before CAR-T cells injection

  11. Cognitive Fatigue subscore

    Time frame: At 2 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  12. Cognitive Fatigue subscore

    Time frame: At 10 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    10 days after CAR-T cells injection

  13. Cognitive Fatigue subscore

    Time frame: At 21 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    21 days after CAR-T cells injection

  14. Cognitive Fatigue subscore

    Time frame: At 30 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    30 days after CAR-T cells injection

  15. Emotional Fatigue subscore

    Time frame: At inclusion

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    5 days before CAR-T cells injection

  16. Emotional Fatigue subscore

    Time frame: At 2 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    2 days after CAR-T cells injection

  17. Emotional Fatigue subscore

    Time frame: At 10 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    10 days after CAR-T cells injection

  18. Emotional Fatigue subscore

    Time frame: At 21 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    21 days after CAR-T cells injection

  19. Emotional Fatigue subscore

    Time frame: At 30 days

    European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue.

    30 days after CAR-T cells injection

  20. Occurence of side events

    Time frame: Until one month

  21. Severity of side events

    Time frame: Until one month

Study contacts

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

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33 1 42 49 97 42 ext. +33

Maxime Berquier, MD

CONTACT

[email protected]

+33142494585 ext. +331424991

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Etude de l'Association Entre la Fatigue Ressentie Par Les Patients et Les Effets Secondaires spécifiques Des CART Cells, au Cours du Premier Mois après l'Administration Pour un Lymphome Non Hodgkinien

Acronym: CAR-TIGUE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

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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