Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07160751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognition and Patients With Lung Cancer
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGNIPULM
Brief Summary:
Cognitive complaints in patients treated for cancer can impact their quality of life.
Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway.
In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time.
The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined.
The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.
Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway.
In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time.
The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined.
The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.
Detailed Description:
Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.
These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.
Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.
They significantly impair functional independence and quality of life for cancer patients.
A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.
Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.
These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.
According to one study, 26% of lung cancer survivors present with CRCI.
Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.
Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.
Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.
Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.
Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.
A French-language framework and international guidelines have been developed to help standardize cognitive assessment.
Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.
Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.
Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).
These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.
Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.
They significantly impair functional independence and quality of life for cancer patients.
A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.
Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.
These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.
According to one study, 26% of lung cancer survivors present with CRCI.
Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.
Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.
Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.
Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.
Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.
A French-language framework and international guidelines have been developed to help standardize cognitive assessment.
Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.
Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.
Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: