Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies
NCT ID: NCT04673305
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-03-31
2023-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1
patients ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months
Cognitive Assessment, Cytokine dosage
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.
Interventions
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Cognitive Assessment, Cytokine dosage
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.
Eligibility Criteria
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Inclusion Criteria
* Signed Informed Consent Form;
* Haematological malignancy diagnosis that requires whithin three months a treatment.
Exclusion Criteria
* Comorbidity or condition that, in the investigator's opinion, may compromise the safe execution of the tests.
70 Years
90 Years
ALL
No
Sponsors
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Associazione Oncologica Milanese AmoLaVita ONLUS
UNKNOWN
Ospedale San Carlo Borromeo
OTHER
Responsible Party
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Vittorio Montefusco
Medical Director Ssd of Oncohaematology
Principal Investigators
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Vittorio Montefusco, MD
Role: PRINCIPAL_INVESTIGATOR
ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
Fabio Frediani, MD
Role: PRINCIPAL_INVESTIGATOR
ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
Locations
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ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL - SSd. Onco - Haematology and SC Neurology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Vittorio Montefusco, MD
Role: primary
References
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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.
Pendergrass JC, Targum SD, Harrison JE. Cognitive Impairment Associated with Cancer: A Brief Review. Innov Clin Neurosci. 2018 Feb 1;15(1-2):36-44.
Ahles TA, Saykin AJ. Candidate mechanisms for chemotherapy-induced cognitive changes. Nat Rev Cancer. 2007 Mar;7(3):192-201. doi: 10.1038/nrc2073.
Ahles 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.
Deprez 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.
Deprez 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.
Simo 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.
McDonald 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.
Hshieh 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.
Allegra 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.
Bradshaw 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
Other Identifiers
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Chemobrain Study
Identifier Type: -
Identifier Source: org_study_id