## Protocol Section
### Identification Module
**NCT ID:** NCT06435559

**Acronym:** CHEMOFOG

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

**Official Title:** CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario

#### Organization Study ID Info
**ID:** CHEMOFOG
#### Organization
**Class:** OTHER
**Full Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- Chemotherapy-induced cognitive impairment

- Neuropsychological assessments

- Breast cancer

- Adjuvant chemotherapy

- Neo-adjuvant chemotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 128

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Neurotablet® and Neuropsychological evaluations

**Label:** A-experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Neuropsychological evaluations

**Label:** B-control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A-experimental group

**Description:** 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.

**Name:** Neurotablet® and Neuropsychological evaluations

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- B-control group

**Description:** 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.

**Name:** Neuropsychological evaluations

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The effectiveness of a 10-week cognitive rehabilitation program

**Time Frame:** 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

**Description:** Analysis of cognitive function trends though neurocognitive evaluations

**Measure:** Analysis of cognitive function trends in the control group

**Time Frame:** 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)

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ornella.garrone@policlinico.mi.it

**Name:** Ornella Garrone, MD

**Phone:** +390255032660

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica

**Name:** Ornella Garrone, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M2440

- Name: Chemotherapy-Related Cognitive Impairment

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
