Cognitive ImpairmentNCT04673305
Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies
A study testing Cognitive Assessment, Cytokine dosage in people with Cognitive Impairment and Haematological Malignancy, run by Ospedale San Carlo Borromeo at 1 site in Italy.
Trial summary
BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and… Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Cognitive Impairment, Haematological Malignancy, Chemo-brain
- What is being tested?
- Cognitive Assessment, Cytokine dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2021to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ages ≥ 70 years;
- Signed Informed Consent Form;
- Haematological malignancy diagnosis that requires whithin three months a treatment.
Who cannot join
- Inability (ex. severe visual and/or hearing impairments, lack of caregivers) to carry out the tests required by the study;
- Comorbidity or condition that, in the investigator's opinion, may compromise the safe execution of the tests.
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL - SSd. Onco - Haematology and SC Neurology
Milan, 20153
Vittorio Montefusco, MD, 00390240222104, vittorio.montefusco@asst-santipaolocarlo.it
Fabio Frediani, MD
About this study
BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and about 35% continue to present cognitive difficulties in the following months/years.
There is growing evidence that cognitive symptoms have a biological mechanism linked to the activation of immunological cytokines that exert important effects on the brain functions. For example, interferon α is known to increase the levels of IL-1, IL-6 and TNF-α, and this increase is associated with memory deficits, executive function and mood alterations.
Read more
A neurotoxic action induced by cytokines has been demonstrated both in the early stages of the tumor and after chemotherapy.
Several imaging studies suggest that the cognitive impairment pattern in cancer patients, during the treatment and in remission, is related to structural and functional brain changes.
Longitudinal studies in women with breast cancer treated with chemoterapy have shown a reduction in the volume of cerebral gray matter, mainly in the bilateral frontal cortex and hippocampus. In parallel, diffusion tensor imaging studies have shown an alteration of the integrity of the frontal, parietal and occipital cerebral white matter, demyelination and axonal degeneration processes. Finally, functional magnetic resonance studies in cancer patients have shown alterations in the connectivity of the default mode network compared to control subjects.
Studies carried out to date, show a prevalent impairment of executive functions and working memory. Cognitive impairment has been studied mainly as a possible adverse effect in women treated with chemotherapy for breast cancer, while there are few studies in the literature on patients with haematological malignancies.
STUDY DESIGN The study is targeted to patients ages ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months.
Once the eligibility criteria have been assessed, the hematologist proposes the enrollment in the study. Once the patient's informed consent has been acquired, a neurological examination is carried out, functional tests required by the protocol are administered. The patient begins, as per clinical practice, the treatment provided for his/her haematological malignancy. Test's evaluation is repeated at 6 months and 12 months after the enrollment. In conjunction with neurological tests, will be performed a venipuncture as per clinical practice, and a blood sample is taken to measure the cytokines involved in inflammatory processes. It is expected that a patient can perform up to a maximum of 3 blood samples for the biological study.
STATISTICAL ANALYSIS This is a non-pharmacological, prospective, uncontrolled, open-label single-center interventional pilot study, aimed to describ the progress of cognitive function under treatment for haematological disease.
Due to the pilot and exploratory nature of the study and the substantial absence of a specific literature relating to the elderly onco-haematological patient, it is not believed that the conditions exist to be able to formally define the size of the sample. The sample size is arbitrarily fixed at 60 patients. The observation time will be 12 months from enrollment.
- Conditions
- Cognitive Impairment, Haematological Malignancy, Chemo-brain
- Being tested
- Cognitive Assessment, Cytokine dosage
- Medical subject headings
- Cognitive Dysfunction, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Assessment, Cytokine dosageOther
Once the patient's informed consent has been acquired, a neurological examination is carried out, with functional tests required by the protocol. The patient carries out, as per clinical practice, the treatment provided for the cure of his disease. The evaluation of the tests is repeated at 6 months and 12 months after enrollment in the study. In conjunction with a venipuncture performed for the exams required by clinical management, a blood sample is taken to measure the cytokines involved in inflammatory processes.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | patients ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months Receives: Other: Cognitive Assessment, Cytokine dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the score trend obtained with the Mini-mental test (MMSE)
MMSE score at 12 months will be compared with the MMSE at enrollment.
Measured: 12 months from the enrollment
Secondary outcomes (8)
Activities of daily living (ADL) score
ADL at 12 months will be compared with ADL at enrollment.
Measured: 12 months from the enrollment
Instrumental activities of daily living (IADL) score
IADL at 12 months will be compared with IADL at enrollment.
Measured: 12 months from the enrollment
Charlson comorbidity index
Charlson comorbidity index at 12 months will be compared with Charlson comorbidity index at enrollment.
Measured: 12 months from the enrollment
CDT (clock drawing test)
CDT at 12 months will be compared with CDT st enrollment.
Measured: 12 months from the enrollment
FAB (frontal assessment battery)
FAB at 12 months will be compared with FAB at enrollment.
Measured: 12 months from the enrollment
Digit Span
Digit Span at 12 months will be compared with Digit Span at enrollment.
Measured: 12 months from the enrollment
CorsiTest
Corsi Test at 12 months will be compared with Corsi Test at enrollment.
Measured: 12 months from the enrollment
STAI-Y test
STAI-Y test at 12 months will be compared with STAI-Y test at enrollment.
Measured: 12 months from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Carlo Borromeo
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Oncologica Milanese AmoLaVita ONLUS
- Responsible party
- Principal investigator, Vittorio Montefusco, Ospedale San Carlo Borromeo
- Investigators
- Vittorio Montefusco, MD, Principal investigator, ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITALFabio Frediani, MD, Principal investigator, ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673305
- Sponsor's protocol ID
- Chemobrain Study
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyers CA, Albitar M, Estey E. Cognitive impairment, fatigue, and cytokine levels in patients with acute myelogenous leukemia or myelodysplastic syndrome. Cancer. 2005 Aug 15;104(4):788-93. doi: 10.1002/cncr.21234.
PubMed 15973668Pendergrass JC, Targum SD, Harrison JE. Cognitive Impairment Associated with Cancer: A Brief Review. Innov Clin Neurosci. 2018 Feb 1;15(1-2):36-44.
PubMed 29497579Ahles TA, Saykin AJ. Candidate mechanisms for chemotherapy-induced cognitive changes. Nat Rev Cancer. 2007 Mar;7(3):192-201. doi: 10.1038/nrc2073.
PubMed 17318212Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24.
PubMed 23008308Deprez S, Amant F, Smeets A, Peeters R, Leemans A, Van Hecke W, Verhoeven JS, Christiaens MR, Vandenberghe J, Vandenbulcke M, Sunaert S. Longitudinal assessment of chemotherapy-induced structural changes in cerebral white matter and its correlation with impaired cognitive functioning. J Clin Oncol. 2012 Jan 20;30(3):274-81. doi: 10.1200/JCO.2011.36.8571. Epub 2011 Dec 19.
PubMed 22184379Deprez S, Billiet T, Sunaert S, Leemans A. Diffusion tensor MRI of chemotherapy-induced cognitive impairment in non-CNS cancer patients: a review. Brain Imaging Behav. 2013 Dec;7(4):409-35. doi: 10.1007/s11682-012-9220-1.
PubMed 23329357Simo M, Rifa-Ros X, Rodriguez-Fornells A, Bruna J. Chemobrain: a systematic review of structural and functional neuroimaging studies. Neurosci Biobehav Rev. 2013 Sep;37(8):1311-21. doi: 10.1016/j.neubiorev.2013.04.015. Epub 2013 May 6.
PubMed 23660455McDonald BC, Conroy SK, Ahles TA, West JD, Saykin AJ. Gray matter reduction associated with systemic chemotherapy for breast cancer: a prospective MRI study. Breast Cancer Res Treat. 2010 Oct;123(3):819-28. doi: 10.1007/s10549-010-1088-4. Epub 2010 Aug 6.
PubMed 20690040Hshieh TT, Jung WF, Grande LJ, Chen J, Stone RM, Soiffer RJ, Driver JA, Abel GA. Prevalence of Cognitive Impairment and Association With Survival Among Older Patients With Hematologic Cancers. JAMA Oncol. 2018 May 1;4(5):686-693. doi: 10.1001/jamaoncol.2017.5674.
PubMed 29494732Allegra A, Innao V, Basile G, Pugliese M, Allegra AG, Pulvirenti N, Musolino C. Post-chemotherapy cognitive impairment in hematological patients: current understanding of chemobrain in hematology. Expert Rev Hematol. 2020 Apr;13(4):393-404. doi: 10.1080/17474086.2020.1738213. Epub 2020 Mar 10.
PubMed 32129131Bradshaw M, Wefel J. The neuropsychology of oncology. In: Parsons M, Hammeke T (eds). Clinical Neuropsychology: A pocket handbook for assessment, Third edition. Washington DC: American Psychological Association; 2014:313-337
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies
- ClinicalTrials.gov ID
- NCT04673305
- Acronym / sponsor ID
- Chemobrain Study
- Conditions
- Cognitive Impairment, Haematological Malignancy, Chemo-brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale San Carlo BorromeoUniversity, hospital or other
- Collaborators
- Associazione Oncologica Milanese AmoLaVita ONLUS
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 Dec 2020 (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.
BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and about 35% continue to present cognitive difficulties in the following months/years.
There is growing evidence that cognitive symptoms have a biological mechanism linked to the activation of immunological cytokines that exert important effects on the brain functions. For example, interferon α is known to increase the levels of IL-1, IL-6 and TNF-α, and this increase is associated with memory deficits, executive function and mood alterations.
A neurotoxic action induced by cytokines has been demonstrated both in the early stages of the tumor and after chemotherapy.
Several imaging studies suggest that the cognitive impairment pattern in cancer patients, during the treatment and in remission, is related to structural and functional brain changes.
Longitudinal studies in women with breast cancer treated with chemoterapy have shown a reduction in the volume of cerebral gray matter, mainly in the bilateral frontal cortex and hippocampus. In parallel, diffusion tensor imaging studies have shown an alteration of the integrity of the frontal, parietal and occipital cerebral white matter, demyelination and axonal degeneration processes. Finally, functional magnetic resonance studies in cancer patients have shown alterations in the connectivity of the default mode network compared to control subjects.
Studies carried out to date, show a prevalent impairment of executive functions and working memory. Cognitive impairment has been studied mainly as a possible adverse effect in women treated with chemotherapy for breast cancer, while there are few studies in the literature on patients with haematological malignancies.
STUDY DESIGN The study is targeted to patients ages ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months.
Once the eligibility criteria have been assessed, the hematologist proposes the enrollment in the study. Once the patient's informed consent has been acquired, a neurological examination is carried out, functional tests required by the protocol are administered. The patient begins, as per clinical practice, the treatment provided for his/her haematological malignancy. Test's evaluation is repeated at 6 months and 12 months after the enrollment. In conjunction with neurological tests, will be performed a venipuncture as per clinical practice, and a blood sample is taken to measure the cytokines involved in inflammatory processes. It is expected that a patient can perform up to a maximum of 3 blood samples for the biological study.
STATISTICAL ANALYSIS This is a non-pharmacological, prospective, uncontrolled, open-label single-center interventional pilot study, aimed to describ the progress of cognitive function under treatment for haematological disease.
Due to the pilot and exploratory nature of the study and the substantial absence of a specific literature relating to the elderly onco-haematological patient, it is not believed that the conditions exist to be able to formally define the size of the sample. The sample size is arbitrarily fixed at 60 patients. The observation time will be 12 months from enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Cognitive Assessment, Cytokine dosagepatients ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Ages ≥ 70 years;
- Signed Informed Consent Form;
- Haematological malignancy diagnosis that requires whithin three months a treatment.
Key exclusion criteria (2 listed)
- Inability (ex. severe visual and/or hearing impairments, lack of caregivers) to carry out the tests required by the study;
- Comorbidity or condition that, in the investigator's opinion, may compromise the safe execution of the tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Assessment, Cytokine dosageOnce the patient's informed consent has been acquired, a neurological examination is carried out, with functional tests required by the protocol. The patient carries out, as per clinical practice, the treatment provided for the cure of his disease. The evaluation of the tests is repeated at 6 months and 12 months after enrollment in the study. In conjunction with a venipuncture performed for the exams required by clinical management, a blood sample is taken to measure the cytokines involved in inflammatory processes. | Other | Arm 1 |
Primary outcome
Evaluation of the score trend obtained with the Mini-mental test (MMSE)
Time frame: 12 months from the enrollment
MMSE score at 12 months will be compared with the MMSE at enrollment.
8 secondary outcomes
Activities of daily living (ADL) score
Time frame: 12 months from the enrollment
Instrumental activities of daily living (IADL) score
Time frame: 12 months from the enrollment
Charlson comorbidity index
Time frame: 12 months from the enrollment
CDT (clock drawing test)
Time frame: 12 months from the enrollment
FAB (frontal assessment battery)
Time frame: 12 months from the enrollment
Digit Span
Time frame: 12 months from the enrollment
CorsiTest
Time frame: 12 months from the enrollment
STAI-Y test
Time frame: 12 months from the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 15973668Meyers CA, Albitar M, Estey E. Cognitive impairment, fatigue, and cytokine levels in patients with acute myelogenous leukemia or myelodysplastic syndrome. Cancer. 2005 Aug 15;104(4):788-93. doi: 10.1002/cncr.21234.
- Background: PubMed 29497579Pendergrass JC, Targum SD, Harrison JE. Cognitive Impairment Associated with Cancer: A Brief Review. Innov Clin Neurosci. 2018 Feb 1;15(1-2):36-44.
- Background: PubMed 17318212Ahles TA, Saykin AJ. Candidate mechanisms for chemotherapy-induced cognitive changes. Nat Rev Cancer. 2007 Mar;7(3):192-201. doi: 10.1038/nrc2073.
- Background: PubMed 23008308Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24.
- Background: PubMed 22184379Deprez S, Amant F, Smeets A, Peeters R, Leemans A, Van Hecke W, Verhoeven JS, Christiaens MR, Vandenberghe J, Vandenbulcke M, Sunaert S. Longitudinal assessment of chemotherapy-induced structural changes in cerebral white matter and its correlation with impaired cognitive functioning. J Clin Oncol. 2012 Jan 20;30(3):274-81. doi: 10.1200/JCO.2011.36.8571. Epub 2011 Dec 19.
- Background: PubMed 23329357Deprez S, Billiet T, Sunaert S, Leemans A. Diffusion tensor MRI of chemotherapy-induced cognitive impairment in non-CNS cancer patients: a review. Brain Imaging Behav. 2013 Dec;7(4):409-35. doi: 10.1007/s11682-012-9220-1.
- Background: PubMed 23660455Simo M, Rifa-Ros X, Rodriguez-Fornells A, Bruna J. Chemobrain: a systematic review of structural and functional neuroimaging studies. Neurosci Biobehav Rev. 2013 Sep;37(8):1311-21. doi: 10.1016/j.neubiorev.2013.04.015. Epub 2013 May 6.
- Background: PubMed 20690040McDonald BC, Conroy SK, Ahles TA, West JD, Saykin AJ. Gray matter reduction associated with systemic chemotherapy for breast cancer: a prospective MRI study. Breast Cancer Res Treat. 2010 Oct;123(3):819-28. doi: 10.1007/s10549-010-1088-4. Epub 2010 Aug 6.
- Background: PubMed 29494732Hshieh TT, Jung WF, Grande LJ, Chen J, Stone RM, Soiffer RJ, Driver JA, Abel GA. Prevalence of Cognitive Impairment and Association With Survival Among Older Patients With Hematologic Cancers. JAMA Oncol. 2018 May 1;4(5):686-693. doi: 10.1001/jamaoncol.2017.5674.
- Background: PubMed 32129131Allegra A, Innao V, Basile G, Pugliese M, Allegra AG, Pulvirenti N, Musolino C. Post-chemotherapy cognitive impairment in hematological patients: current understanding of chemobrain in hematology. Expert Rev Hematol. 2020 Apr;13(4):393-404. doi: 10.1080/17474086.2020.1738213. Epub 2020 Mar 10.
- BackgroundBradshaw M, Wefel J. The neuropsychology of oncology. In: Parsons M, Hammeke T (eds). Clinical Neuropsychology: A pocket handbook for assessment, Third edition. Washington DC: American Psychological Association; 2014:313-337
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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. This study is not recruiting at the moment.
Vittorio Montefusco, MD principal investigator
ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
Fabio Frediani, MD principal investigator
ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Assessment, Cytokine dosage in people with Cognitive Impairment and Haematological Malignancy, run by Ospedale San Carlo Borromeo at 1 site in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vittorio Montefusco, MD (00390240222104, vittorio.montefusco@asst-santipaolocarlo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the score trend obtained with the Mini-mental test (MMSE) (time frame: 12 months from the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673305, which also lists 11 linked publications.
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 17 Dec 2020.