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

NCT06435559 | Not Yet Recruiting

• 1 other identifier: CHEMOFOG
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Chemotherapy-induced cognitive impairment; Neuropsychological assessments; Breast cancer; Adjuvant chemotherapy; Neo-adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• The effectiveness of a 10-week cognitive rehabilitation program

  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.

  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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

A-experimental group

EXPERIMENTAL

Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises

Other: Neurotablet® and Neuropsychological evaluations

B-control group

OTHER

Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises.

Other: Neuropsychological evaluations

Interventions

Neurotablet® and Neuropsychological evaluations OTHER

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.

A-experimental group

Neuropsychological evaluations OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of informed consent
• Diagnosis of operable/operated breast cancer
• Patients candidate to be treated with Neo/adjuvant chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Related Publications (27)

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MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ornella Garrone, MD

  Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ornella Garrone, MD

CONTACT

+390255032660; ornella.garrone@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05