Study of the Cognition of Patients Treated With Immunotherapy

Not Applicable

Completed

• Conditions: Patients With Cancer Who Start Immunotherapy; All Neoplasms
• Interventions: Other: Cognitive test passations

• Registration Number: NCT03599830
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.

Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.

The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study Start: 2018-07-10
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patient over the age of 18,
• Patient with cancer and having to initiate treatment with immunotherapy alone
• Treatment with immunotherapy will include either an anti-PD1 / L1 or Anti CTLA4 monotherapy or combination,
• Patients may have received other antitumor treatments other than immunotherapy but these should be stopped at the time of initiation of immunotherapy
• Performance Status <2
• Patient at the level of studies 3 "end of primary studies" minimum (Barbizet scale),
• Mastery of the French language.
• Patient affiliated to a social security system
• Patient having attested in writing of his non-opposition to participate in the study

Exclusion Criteria

• Previous treatment with immunotherapy
• Another anti-tumor treatment underway
• Primary cancer of the central nervous system or cerebral metastasis, symptomatics and not controlled
• Abuse of alcohol or drug use
• Severe visual and / or auditory deficiency,
• Refusal of participation of the patient.
• Patient deprived of liberty or under guardianship
• Patient unable to follow the study for geographical, social or psychopathological reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive test passations	Cognitive test passations	3 neuropsychological passations over a period of 6 months.

Primary Outcome Measures

Name	Time	Method
Change in cognitive function (at least in a cognitive domain)	between inclusion and 3 months.	The proportion of patients who will have a reduction of scores in neuropsychological questionnaires (scores of MoCA2, Hopkins verbal learning test, WAIS-IV, Trail Making test, Stroop Symboles)

Trial Locations

Locations (4)

Centre François Baclesse; 🇫🇷 Caen, France

Chru Lille; 🇫🇷 Lille, France

Chu Amiens; 🇫🇷 Amiens, France

CHU CAEN; 🇫🇷 Caen, France