Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Chemotherapy-induced Peripheral Neuropathy. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Primary outcome measures
- chemotherapy-induced peripheral neuropathy [Time frame: 1 year, 2 years]
- psychological impact of chemotherapy adminstration [Time frame: 1 year, 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Sohag University — Sohag
Identifiers
NCT: NCT07184749 · Soh-Med-25-7-8PD · Sohag University