Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study

Despite growing awareness of neurocognitive and psychological complications of systemic chemotherapy administration in breast cancer, prospective observational studies evaluating such effects in Egyptian breast cancer patients-especially with pre- and post-treatment assessments-remain limited. Given the rising incidence of breast cancer in Egypt and the growing population of long-term survivors, it is essential to investigate the extent and nature of cognitive and psychological changes associated with treatment. The current study aims to fill this gap by prospectively evaluating neurological, cognitive, and psychological parameters in newly diagnosed breast cancer patients, using validated tools before and one year after treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Chemotherapy-induced Peripheral Neuropathy

Detailed Description

Patient Recruitment This prospective observational study will include female breast cancer patients who will be recruited from the neuropsychiatry, Clinical Oncology, and general surgery departments, as well as from outpatient clinics at Sohag University Hospital.

Inclusion Criteria Female patients with newly diagnosed breast cancer will be included. All patients will be evaluated before the initiation of treatment and again one year after treatment completion.

Study Methodology

All enrolled patients will undergo the following assessments:

Complete History taking: thorough medical, neurological, and oncological history will be obtained, including comorbidities and current medications.

Neurological Examination: Each patient will receive a comprehensive clinical neurological examination at baseline and one year after treatment.

Neuroimaging: Brain MRI will be performed to detect any structural brain abnormalities or metastatic lesions.

Neurophysiological Assessment Nerve conduction studies (NCS) will be conducted to evaluate for peripheral neuropathy.

Cognitive Function Assessment

Cognitive testing will be carried out at baseline and at the one-year follow-up using the following tools:

A. Wisconsin Card Sorting Test (WCST) This test will assess executive functions such as cognitive flexibility and set shifting.

Higher perseverative error scores will indicate poorer performance (7). B. Trail Making Test (TMT), Parts A & B Part A: Patients will connect sequential numbers to assess visual attention and processing speed.

Part B: Patients will alternate between numbers and letters (1-A-2-B…) to assess executive functioning.

Errors will be corrected by the examiner in real time (8). C. Montreal Cognitive Assessment (MoCA) This test will evaluate attention, memory, language, executive functions, visuospatial skills, and orientation.

Total score: 0-30, with higher scores indicating better function. (Nasreddine et al., 2005)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Alshaymaa Abdelghaffar, MD, PhD; Phone Number: +201006828975; Email: drshaymaa_sharaka@outlook.sa
• Study Contact Backup: Name: Ahmed Abugharib, MD, PhD; Email: Ahmed.abugharib@tbh.net

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University
    • Contact: Alshaymaa Abdelghaffar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients with newly diagnosed breast cancer for whom chemotherapy is prescribed

Description

Inclusion Criteria:

1. Newly diagnosed breast cancer female patients.
2. Chemotherapy is indicated for these patients either preoperative or postoperative.

Exclusion Criteria:

1. known history of neurological disease.
2. presence of symptoms suggesting positive neurological disease.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemotherapy-induced peripheral neuropathy	FACT/GOG-Ntx questionnaire	1 year, 2 years
psychological impact of chemotherapy adminstration	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire Total Neuropathy Score (TNS) EORTC QLQ-CIPN20 questionnaire Patient Neurotoxicity Questionnaire	1 year, 2 years

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Alshaymaa Ahmed, MD, PhD, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 30, 2025
• First Submitted That Met QC Criteria: September 13, 2025
• First Posted (Actual): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Soh-Med-25-7-8PD; Sohag University (Other Identifier: Sohag University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No