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

NCT07184749 | Not Yet Recruiting DMC

• 2 other identifiers: Soh-Med-25-7-8PDSohag University
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• chemotherapy-induced peripheral neuropathy

  FACT/GOG-Ntx questionnaire

  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

  1 year, 2 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with newly diagnosed breast cancer for whom chemotherapy is prescribed

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alshaymaa Ahmed, MD, PhD

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alshaymaa Abdelghaffar, MD, PhD

CONTACT

+201006828975; drshaymaa_sharaka@outlook.sa

Ahmed Abugharib, MD, PhD

CONTACT

Ahmed.abugharib@tbh.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

EG (1)