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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07184749
- Acronym / sponsor ID
- Soh-Med-25-7-8PD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with newly diagnosed breast cancer for whom chemotherapy is prescribed
Key inclusion criteria (2 listed)
- Newly diagnosed breast cancer female patients.
- Chemotherapy is indicated for these patients either preoperative or postoperative.
Key exclusion criteria (2 listed)
- known history of neurological disease.
- presence of symptoms suggesting positive neurological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
chemotherapy-induced peripheral neuropathy
Time frame: 1 year, 2 years
FACT/GOG-Ntx questionnaire
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Abugharib, MD, PhD contact
Alshaymaa Ahmed, MD, PhD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa Abdelghaffar, MD, PhD (+201006828975, drshaymaa_sharaka@outlook.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chemotherapy-induced peripheral neuropathy (time frame: 1 year, 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.