Evaluation of Chemotherapy-induced Cognitive Disorders During the Treatment of Hematological Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: patient group
Group B: control group
Trial outcomes
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."
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)Secondary outcomes
1
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.
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)2
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.
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)3
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.
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)4
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.
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)Sponsors and contacts
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Source ClinicalTrials.gov