Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-19
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:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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 11 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 11 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:
None
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?:
None