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

NCT07147621 | Recruiting

• 1 other identifier: 49RC25_0247
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive complaints measured by the Functional Assessment of Cancer Therapy - Cognitive function (FACT-Cog) questionnaire

  "Changes in cognitive complaints are measured by comparing the FACT-Cog scores obtained in the patient group and in the control group (intra- and inter-group comparison) before chemotherapy and 6 months after chemotherapy. The FACT-Cog questionnaire is a self-administered questionnaire used to measure cognitive complaints in cancer patients. It consists of 37 questions divided into 4 sections: Perceived Cognitive Impairment (20 questions, score range: 0-72), Comments From Others (4 questions, score range: 0-16), Perceived Cognitive Abilities (9 questions, score -range: 0-28), and Impact on Quality of Life (4 questions, score range: 0-16). Each question is assessed on a 5-point Likert scale. Higher scores indicate lower cognitive complaints."

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

Secondary Outcomes (15)

• Changes in the scores obtained on the MoCA test

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

• Changes in the scores obtained on the WAIS-IV Information test

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

• Changes in the scores obtained on the Hopkins Verbal Learning Test.

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

• Changes in the scores obtained on the TMT parts A and B.

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

• Changes in the scores obtained on the WAIS-IV Codes test.

  Baseline At the end of the last chemotherapy cycle (up to 6 months after baseline, depending on the type of chemotherapy) Six months after chemotherapy (up to 1 year after baseline)

Study Arms (2)

patient group

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the patient group will be recruited from the Hematology Departments of 2 French academic centers (Angers and Brest University Hospitals). Participants in the control group will be selected among the patient's relatives (family, friends, colleagues, etc.) of the same age category (less than 5 years of difference) and with the same education level.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital of Angers

Angers, Maine et Loire, 49933, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

SCHMIDT ALINE, MD, PhD

CONTACT

2 41 35 44 82; AlSchmidt@chu-angers.fr

Darras Elise, PharmD

CONTACT

241355925; Elise.Darras@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 29, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)