Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment

Phase 4

Completed

• Conditions: Braest Cancer; Dry Eye
• Interventions: Drug: Hormonal treatment

• Registration Number: NCT06924229
• Lead Sponsor: Sohag University

Brief Summary

Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment.

Detailed Description

Aromatase inhibitors (AI) therapy is an important treatment for estrogen receptor-positive breast cancer (BC). This work evaluated the eye anterior segment changes in estrogen-dependent BC after hormonal treatment.

This cross-sectional study was conducted on female patients aged ≥18 who received treatment for BC. Patients were evaluated by a number of tests to determine the effects on the cornea and the lacrimal system

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Females diagnosed with breast cancer

Exclusion Criteria

• uncontrolled diabetes , auto immune diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with breast cancer recieving hormonal treatment	Hormonal treatment	evaluation of the effect of hormonal treatment on the cornea

Primary Outcome Measures

Name	Time	Method
tear break up time test and shirmer test	6 months	these tests done before starting treatment and in follow up after recieving treatment to evaluate the lacrimal function and dry eye

Secondary Outcome Measures

Name	Time	Method
Corneal thickness and endothelium hexagonality	6 months	Corneal thickness and hesagonality were evaluated before and after treatment with aromatase inhibitors

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt