Fatigue SymptomCAR-TIGUENCT06890091
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
An observational study of Fatigue Symptom and Lymphoma Non-Hodgkin, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Symptom, Lymphoma Non-Hodgkin, Chimeric Antigen Receptor T-cell Therapy
- What is being tested?
- Fatigue assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma
Who may be able to join
- 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.
Who cannot join
- Patient under legal protection
- Opposition to research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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?"
- Conditions
- Fatigue Symptom, Lymphoma Non-Hodgkin, Chimeric Antigen Receptor T-cell Therapy, Adverse Events
- Being tested
- Fatigue assessment
- Keywords
- Fatigue, CAR-T cells, Chimeric antigen receptor, Adverse events, Lymphoma Non-Hodgkin, Nurse practitionners
- Medical subject headings
- Fatigue, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue assessmentOther
Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale
| Study group | Role | What they receive |
|---|---|---|
| Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma | Not described Receives: Other: Fatigue assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue score
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
Measured: At day 30
Secondary outcomes (21)
Fatigue score
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
Measured: At inclusion
Fatigue score
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
Measured: At day 2
Fatigue score
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
Measured: At day 10
Fatigue score
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
Measured: At day 21
Physical Fatigue subscore
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
Measured: At inclusion
Physical Fatigue subscore
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
Measured: At day 2
Physical Fatigue subscore
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
Measured: At day 10
Physical Fatigue subscore
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
Measured: At day 21
Physical Fatigue subscore
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
Measured: At day 30
Cognitive Fatigue subscore
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
Measured: At inclusion
Cognitive Fatigue subscore
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
Measured: At 2 days
Cognitive Fatigue subscore
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
Measured: At 10 days
Cognitive Fatigue subscore
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
Measured: At 21 days
Cognitive Fatigue subscore
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
Measured: At 30 days
Emotional Fatigue subscore
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
Measured: At inclusion
Emotional Fatigue subscore
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
Measured: At 2 days
Emotional Fatigue subscore
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
Measured: At 10 days
Emotional Fatigue subscore
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
Measured: At 21 days
Emotional Fatigue subscore
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
Measured: At 30 days
Occurence of side events
Measured: Until one month
Severity of side events
Measured: Until one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue SymptomStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890091
- Sponsor's protocol ID
- APHP241779
- Acronym
- CAR-TIGUE
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06890091
- Acronym / sponsor ID
- CAR-TIGUE / APHP241779
- Conditions
- Fatigue Symptom, Lymphoma Non-Hodgkin, Chimeric Antigen Receptor T-cell Therapy, Adverse Events
- Keywords
- Fatigue, CAR-T cells, Chimeric antigen receptor, Adverse events, Lymphoma Non-Hodgkin, Nurse practitionners
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?"
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma | – | Other: Fatigue assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient under legal protection
- Opposition to research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue assessmentFatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale | Other | Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma |
Primary outcome
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
21 secondary outcomes
Fatigue score
Time frame: At inclusion
Fatigue score
Time frame: At day 2
Fatigue score
Time frame: At day 10
Fatigue score
Time frame: At day 21
Physical Fatigue subscore
Time frame: At inclusion
Physical Fatigue subscore
Time frame: At day 2
Physical Fatigue subscore
Time frame: At day 10
Physical Fatigue subscore
Time frame: At day 21
Physical Fatigue subscore
Time frame: At day 30
Cognitive Fatigue subscore
Time frame: At inclusion
Cognitive Fatigue subscore
Time frame: At 2 days
Cognitive Fatigue subscore
Time frame: At 10 days
Cognitive Fatigue subscore
Time frame: At 21 days
Cognitive Fatigue subscore
Time frame: At 30 days
Emotional Fatigue subscore
Time frame: At inclusion
Emotional Fatigue subscore
Time frame: At 2 days
Emotional Fatigue subscore
Time frame: At 10 days
Emotional Fatigue subscore
Time frame: At 21 days
Emotional Fatigue subscore
Time frame: At 30 days
Occurence of side events
Time frame: Until one month
Severity of side events
Time frame: Until one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Fatigue Symptom
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Symptom and Lymphoma Non-Hodgkin, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime Berquier, MD (+33142494585 ext. +331424991, maxime.berquier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue score (time frame: At day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.