Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies

December 14, 2020 updated by: Vittorio Montefusco, Ospedale San Carlo Borromeo

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20153
        • ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL - SSd. Onco - Haematology and SC Neurology
        • Principal Investigator:
          • Vittorio Montefusco, MD
        • Contact:
        • Principal Investigator:
          • Fabio Frediani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
patients ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months from the enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of daily living (ADL) score
Time Frame: 12 months from the enrollment
ADL at 12 months will be compared with ADL at enrollment.
12 months from the enrollment
Instrumental activities of daily living (IADL) score
Time Frame: 12 months from the enrollment
IADL at 12 months will be compared with IADL at enrollment.
12 months from the enrollment
Charlson comorbidity index
Time Frame: 12 months from the enrollment
Charlson comorbidity index at 12 months will be compared with Charlson comorbidity index at enrollment.
12 months from the enrollment
CDT (clock drawing test)
Time Frame: 12 months from the enrollment
CDT at 12 months will be compared with CDT st enrollment.
12 months from the enrollment
FAB (frontal assessment battery)
Time Frame: 12 months from the enrollment
FAB at 12 months will be compared with FAB at enrollment.
12 months from the enrollment
Digit Span
Time Frame: 12 months from the enrollment
Digit Span at 12 months will be compared with Digit Span at enrollment.
12 months from the enrollment
CorsiTest
Time Frame: 12 months from the enrollment
Corsi Test at 12 months will be compared with Corsi Test at enrollment.
12 months from the enrollment
STAI-Y test
Time Frame: 12 months from the enrollment
STAI-Y test at 12 months will be compared with STAI-Y test at enrollment.
12 months from the enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IL-1 levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of IL-1 levels with cognitive functions.
12 months from the enrollment
Serum IL-2 levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of IL-2 levels with cognitive functions.
12 months from the enrollment
Serum IL-6 levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of IL-6 levels with cognitive functions.
12 months from the enrollment
Serum TNFα levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of TNFα levels with cognitive functions.
12 months from the enrollment
Serum IL-4 levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of IL-4 levels with cognitive functions.
12 months from the enrollment
Serum IL-10 levels (pg/ml)
Time Frame: 12 months from the enrollment
Correlations of IL-10 levels with cognitive functions.
12 months from the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Carlo Borromeo

Collaborators

Associazione Oncologica Milanese AmoLaVita ONLUS

Investigators

  • Principal Investigator: Vittorio Montefusco, MD, ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL
  • Principal Investigator: Fabio Frediani, MD, ASST SANTI PAOLO CARLO - SAN CARLO BORROMEO HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chemobrain Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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