Clinical trial NCT04673305: Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies
Official title: Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Haematological Malignancy
Chemo-brain
Lead sponsor: Ospedale San Carlo Borromeo
Sponsor class: OTHER
Collaborators: name: Associazione Oncologica Milanese AmoLaVita ONLUS
First posted: 2020-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Ages ≥ 70 years;
* Signed Informed Consent Form;
* Haematological malignancy diagnosis that requires whithin three months a treatment.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of the score trend obtained with the Mini-mental test (MMSE)
timeFrame: 12 months from the enrollment
Secondary outcomes:
measure: Activities of daily living (ADL) score
timeFrame: 12 months from the enrollment
measure: Instrumental activities of daily living (IADL) score
timeFrame: 12 months from the enrollment
measure: Charlson comorbidity index
timeFrame: 12 months from the enrollment
measure: CDT (clock drawing test)
timeFrame: 12 months from the enrollment
measure: FAB (frontal assessment battery)
timeFrame: 12 months from the enrollment
measure: Digit Span
timeFrame: 12 months from the enrollment
measure: CorsiTest
timeFrame: 12 months from the enrollment
measure: STAI-Y test
timeFrame: 12 months from the enrollment
Other outcomes:
measure: Serum IL-1 levels (pg/ml)
timeFrame: 12 months from the enrollment
measure: Serum IL-2 levels (pg/ml)
timeFrame: 12 months from the enrollment
measure: Serum IL-6 levels (pg/ml)
timeFrame: 12 months from the enrollment
measure: Serum TNFα levels (pg/ml)
timeFrame: 12 months from the enrollment
measure: Serum IL-4 levels (pg/ml)
timeFrame: 12 months from the enrollment
measure: Serum IL-10 levels (pg/ml)
timeFrame: 12 months from the enrollment
Locations:
city: Milan
country: Italy
facility: ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL - SSd. Onco - Haematology and SC Neurology
Study officials:
affiliation: ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
name: Vittorio Montefusco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
name: Fabio Frediani, MD
role: PRINCIPAL_INVESTIGATOR
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