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NCT Number: NCT07147621

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin's Lymphoma Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Angers

Angers, Maine et Loire, 49933, France

Location status: Recruiting

Location contact

AUBE-NATHIER Anne-Catherine, PhD

CONTACT

[email protected]

241355496 ext. +33

Darras Elise, PharmD

CONTACT

[email protected]

241355925 ext. +33

SCHMIDT ALINE, MD, PHD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

Primary outcomes

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

    Time frame: 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 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."

Secondary outcomes

  1. Changes in the scores obtained on the MoCA test

    Time frame: 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)

    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.

  2. Changes in the scores obtained on the WAIS-IV Information test

    Time frame: 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)

    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.

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

    Time frame: 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)

    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.

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

    Time frame: 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)

    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.

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

    Time frame: 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)

    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.

  6. Changes in the scores obtained on the forward and reverse digit span memory test.

    Time frame: 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)

    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.

  7. Changes in the scores obtained on the Baddeley's dual task.

    Time frame: 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)

    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.

  8. Changes in the scores obtained on the 'P' and 'Animal' verbal fluency test.

    Time frame: 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)

    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.

  9. Changes in the scores obtained on the Stroop test.

    Time frame: 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)

    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

  10. Changes in the scores obtained on the quality of life questionnaire

    Time frame: 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)

    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.

  11. Changes in the scores obtained on the fatigue questionnaire.

    Time frame: 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)

    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.

  12. Changes in the scores obtained on the anxiety and depression questionnaire.

    Time frame: 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)

    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.

  13. Logistic regression between patient's characteristics and evolution of cognitive complaints measured by the FACT-Cog questionnaire.

    Time frame: 6 months after chemotherapy

  14. 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)

    Time frame: 6 months after chemotherapy

  15. 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

    Time frame: 6 months after chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Darras Elise, PharmD

CONTACT

[email protected]

241355925 ext. +33

SCHMIDT ALINE, MD, PhD

CONTACT

[email protected]

2 41 35 44 82 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: HematoBrain

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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