Evaluation of Chemotherapy-induced Cognitive Disorders During the Treatment of Hematological Malignancies

NCT ID: NCT07147621

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-10-31

Brief Summary

Chemotherapy-induced cognitive disorders, such as memory problems, slowness of execution, inability to concentrate, and language difficulties, are sequelae that occur in patients undergoing chemotherapy or who have received chemotherapy. These symptoms lead to a degradation of the patients' quality of life and can have a significant social and familial impact. They are most commonly described in solid oncology, particularly in patients with breast cancer. Data about patients with hematological malignancies are scarce, but they seem to show the same phenomenon as in solid oncology. Indeed, many chemotherapies are used both in hematology and solid oncology and may therefore cause similar effects on cognition. Additionally, due to their mechanism of action, some chemotherapies specifically used in hematology could induce cognitive disorders. Hematology-treated patients are probably also affected by these disorders and may consequently experience a reduced quality of life.

The objective of this study is to assess the changes in cognitive functions in patients receiving chemotherapy for the treatment of hematological malignancies, using neuropsychological tests and a self-administered questionnaire, compared to a control group, as well as their potential impact on quality of life, fatigue, anxiety, and depression.

Conditions

Acute Myeloid Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

patient group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• adult patient with acute myeloid leukemia, Hodgkin's lymphoma, or non-Hodgkin's lymphoma;
• patient receiving a fixed-duration first-line chemotherapy;
• patient affiliated or beneficiary of a social security scheme; .signed inform consent form.

• adult;
• patient's relative (spouse, brother, sister, friend, etc.);
• less than 5 years of difference with the patient;
• same educational level (< baccalaureate/high school degree, baccalaureate/high school degree level, 2-year university degree, > 2-year university degree);
• person affiliated or beneficiary of a social security scheme;
• signed informed consent form

Exclusion Criteria

• no patient's relative for the control group;
• known or suspective cognitive disorders prior to chemotherapy;
• history of severe neurological or psychiatric disorders (e.g., severe depression); .previous chemotherapy;
• previous brain radiotherapy;
• ongoing treatments affecting cognition;
• patient unable to read;
• patient not speaking French;
• person deprived of liberty by judicial or administrative decision;
• person under forced psychiatric care;
• person under legal protection measures;
• person unable to express consent; .pregnant or breastfeeding woman.

• known or suspected cognitive disorders;
• history of severe neurological or psychiatric disorder (e.g., severe depression); .previous chemotherapy;
• previous brain radiotherapy;
• ongoing treatments affecting cognition;
• person unable to read;
• person not speaking French;
• person deprived of liberty by judicial or administrative decision;
• person under forced psychiatric care;
• person under legal protection measures;
• person unable to express consent;
• pregnant or breastfeeding woman."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Angers

Angers, Maine et Loire, France

Countries

France

Central Contacts

SCHMIDT ALINE, MD, PhD

Role: CONTACT

AlSchmidt@chu-angers.fr

2 41 35 44 82 ext. 33

Darras Elise, PharmD

Role: CONTACT

Elise.Darras@chu-angers.fr

241355925 ext. +33

Facility Contacts

Darras Elise, PharmD

Role: primary

Elise.Darras@chu-angers.fr

241355925 ext. +33

AUBE-NATHIER Anne-Catherine, PhD

Role: backup

acaube-nathier@chu-angers.fr

241355496 ext. +33

Other Identifiers

49RC25_0247

Identifier Type: -

Identifier Source: org_study_id