Acute Myeloid LeukemiaHematoBrainNCT07147621
Evaluation of Chemotherapy-induced Cognitive Disorders During the Treatment of Hematological Malignancies
An observational study of Acute Myeloid Leukemia and Hodgkin's Lymphoma, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, Maine et Loire, 49933
Darras Elise, PharmD, 241355925 ext. +33, Elise.Darras@chu-angers.fr
AUBE-NATHIER Anne-Catherine, PhD, 241355496 ext. +33, acaube-nathier@chu-angers.fr
About this study
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.
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 6 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start26 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147621
- Sponsor's protocol ID
- 49RC25_0247
- Acronym
- HematoBrain
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chemotherapy-induced Cognitive Disorders During the Treatment of Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07147621
- Acronym / sponsor ID
- HematoBrain / 49RC25_0247
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Patient group inclusion criteria:
- Control group inclusion criteria:
Key exclusion criteria (24 listed)
- Patient group exclusion criteria:
- Control group exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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."
15 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Logistic regression between patient's characteristics and evolution of cognitive complaints measured by the FACT-Cog questionnaire.
Time frame: 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)
Time frame: 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
Time frame: 6 months after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Hodgkin's Lymphoma, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SCHMIDT ALINE, MD, PhD (2 41 35 44 82 ext. 33, AlSchmidt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.