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NCT Number: NCT07184749

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Sohag University

Sohag, 82524, Egypt

Location contact

Alshaymaa Abdelghaffar

CONTACT

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known history of neurological disease.
  • presence of symptoms suggesting positive neurological disease.

Treatment and study plan

Primary outcomes

  1. chemotherapy-induced peripheral neuropathy

    Time frame: 1 year, 2 years

    FACT/GOG-Ntx questionnaire

  2. psychological impact of chemotherapy adminstration

    Time frame: 1 year, 2 years

    Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire

    Total Neuropathy Score (TNS)

    EORTC QLQ-CIPN20 questionnaire

    Patient Neurotoxicity Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abugharib, MD, PhD

CONTACT

[email protected]

Alshaymaa Abdelghaffar, MD, PhD

CONTACT

[email protected]

+201006828975

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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