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Trial Title:
CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
NCT ID:
NCT06435559
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Chemotherapy-induced cognitive impairment
Neuropsychological assessments
Breast cancer
Adjuvant chemotherapy
Neo-adjuvant chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Neurotablet® and Neuropsychological evaluations
Description:
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.
Arm group label:
A-experimental group
Intervention type:
Other
Intervention name:
Neuropsychological evaluations
Description:
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.
Arm group label:
B-control group
Summary:
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of
cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment
(CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or
adjuvant therapy.
Detailed description:
This interventional, non-pharmacological, monocentric study examines the effectiveness of
cognitive rehabilitation in counteracting CRCI in women with operable breast cancer
treated with neo-adjuvant therapy and/ or adjuvant therapy.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signature of informed consent
- Diagnosis of operable/operated breast cancer
- Patients candidate to be treated with Neo/adjuvant chemotherapy
Exclusion Criteria:
- Previous chemotherapy treatments
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Agency class:
Other
Source:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435559
