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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: SCHMIDT ALINE, MD, PhD; Phone Number: 33 2 41 35 44 82; Email: AlSchmidt@chu-angers.fr
• Study Contact Backup: Name: Darras Elise, PharmD; Phone Number: +33 241355925; Email: Elise.Darras@chu-angers.fr

Study Locations

• France
  • Maine et Loire
    • Angers, Maine et Loire, France, 49933
      • Recruiting
      • University Hospital of Angers
      • Contact: Darras Elise, PharmD; Phone Number: +33 241355925; Email: Elise.Darras@chu-angers.fr
      • Contact: AUBE-NATHIER Anne-Catherine, PhD; Phone Number: +33 241355496; Email: acaube-nathier@chu-angers.fr
      • Principal Investigator: SCHMIDT ALINE, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• Patient group 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.

• Control group inclusion criteria:

  • 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:

• Patient group 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.

• Control group exclusion criteria:

  • 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."

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control group
patient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the scores obtained on the MoCA test	Comparison of the scores obtained on the MoCA test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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	Comparison of the scores obtained on the WAIS-IV Information test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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.	Comparison of the scores obtained on the Hopkins Verbal Learning Test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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.	Comparison of the scores obtained on the TMT parts A and B in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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.	Comparison of the scores obtained on the WAIS-IV Codes test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 forward and reverse digit span memory test.	Comparison of the scores obtained on the forward and reverse digit span memory test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 Baddeley's dual task.	Comparison of the scores obtained on the Baddeley's dual task in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 'P' and 'Animal' verbal fluency test.	Comparison of the scores obtained on the 'P' and 'Animal' verbal fluency test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 Stroop test.	Comparison of the scores obtained on the Stroop test in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy	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 quality of life questionnaire	Comparison of the scores obtained on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer) in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 fatigue questionnaire.	Comparison of the scores obtained on the FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue Scale) questionnaire in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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 anxiety and depression questionnaire.	Comparison of the scores obtained on the Hospital Anxiety and Depression Scale (HAD scale) in the patient group and in the control group before chemotherapy, after chemotherapy and 6 months after chemotherapy.	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)
Logistic regression between patient's characteristics and evolution of cognitive complaints measured by the FACT-Cog questionnaire.		6 months after chemotherapy
a) Correlation between the score on the FACT-Cog and the scores on objective neuropsychological tests (MoCA, WAIS-IV, Hopkins Verbal Test, WAIS-IV, TMT parts A and B, digit span memory test, Baddeley's dual, "P" and "Animal" verbal fluencies, stroop)		6 months after chemotherapy
b) Correlation between the score on the FACT-Cog questionnaire and the scores on quality of life (EORTC-QLQ-C30), fatigue (FACIT-Fatigue), anxiety and depression (HADS) questionnaires		6 months after chemotherapy

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 5, 2025
• First Submitted That Met QC Criteria: August 28, 2025
• First Posted (Actual): August 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 49RC25_0247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No