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

Обзор

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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Changes in the scores obtained on the MoCA test [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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."

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• University Hospital of Angers — Angers

Идентификаторы

NCT: NCT07147621 · 49RC25_0247

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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