CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Other: Neurotablet® and Neuropsychological evaluations; Other: Neuropsychological evaluations

• Registration Number: NCT06435559
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-experimental group	Neurotablet® and Neuropsychological evaluations	Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises
B-control group	Neuropsychological evaluations	Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises.

Primary Outcome Measures

Name	Time	Method
The effectiveness of a 10-week cognitive rehabilitation program	Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)	Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed.

Secondary Outcome Measures

Name	Time	Method
Analysis of cognitive function trends in the control group	Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)	Analysis of cognitive function trends though neurocognitive evaluations