Breast CancerNCT07184749
Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study
An observational study of Breast Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Peripheral Neuropathy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Sep 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with newly diagnosed breast cancer for whom chemotherapy is prescribed
Who may be able to join
- Newly diagnosed breast cancer female patients.
- Chemotherapy is indicated for these patients either preoperative or postoperative.
Who cannot join
- known history of neurological disease.
- presence of symptoms suggesting positive neurological disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Abugharib, MD, PhD contact
About this 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.
Read the 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:
- 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)
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
chemotherapy-induced peripheral neuropathy
FACT/GOG-Ntx questionnaire
Measured: 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
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaymaa Abdelghaffar, Sohag University
- Investigators
- Alshaymaa Ahmed, MD, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184749
- Sponsor's protocol ID
- Soh-Med-25-7-8PD
- Other IDs
- Sohag University
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No