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

NCT ID: NCT07184749

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-09-30

Brief Summary

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.

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)

Conditions

Breast Cancer; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Alshaymaa Abdelghaffar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alshaymaa Ahmed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Sohag University

Sohag, , Egypt

Countries

Egypt

Central Contacts

Alshaymaa Abdelghaffar, MD, PhD

Role: CONTACT

drshaymaa_sharaka@outlook.sa

+201006828975

Ahmed Abugharib, MD, PhD

Role: CONTACT

Ahmed.abugharib@tbh.net

Facility Contacts

Alshaymaa Abdelghaffar

Role: primary

Other Identifiers

Sohag University

Identifier Type: OTHER

Identifier Source: secondary_id

Soh-Med-25-7-8PD

Identifier Type: -

Identifier Source: org_study_id