Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-11 @ 8:58 AM
Study NCT ID:
NCT06435559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Organization:
Study Overview
Official Title:
CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHEMOFOG
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: