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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Other: Neuropsychological evaluations; Other: Neurotablet® and Neuropsychological evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT06435559

CHEMOFOG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

A-experimental group

Experimental group

Description:

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

Treatment:

Other: Neurotablet® and Neuropsychological evaluations

B-control group

Other group

Description:

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

Treatment:

Other: Neuropsychological evaluations