CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
NCT ID: NCT06435559
Last Updated: 2024-05-30
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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NOT_YET_RECRUITING
NA
128 participants
INTERVENTIONAL
2024-06-01
2026-06-01
Brief Summary
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Detailed Description
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A total of 128 patients will be randomized 1:1 into two groups:
* Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed.
* Control group, which will only carry out neuropsychological assessments.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A-experimental group
Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises
Neurotablet® and Neuropsychological evaluations
The experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
B-control group
Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises.
Neuropsychological evaluations
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Interventions
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Neurotablet® and Neuropsychological evaluations
The experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Neuropsychological evaluations
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of operable/operated breast cancer
* Patients candidate to be treated with Neo/adjuvant chemotherapy
Exclusion Criteria
* Patients with Metastatic breast cancer
* Patients affected by pathologies of the brain, head trauma, and intellectual disabilities
* Patients affected by previous or current neurological and/or psychiatric disorders
* Patients currently treated with psychopharmacological drug
18 Years
75 Years
FEMALE
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Ornella Garrone, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica
Central Contacts
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References
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Other Identifiers
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CHEMOFOG
Identifier Type: -
Identifier Source: org_study_id
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