Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment (breast cancer)

April 4, 2025 updated by: Haitham Thabit, Sohag University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females diagnosed with breast cancer

Exclusion Criteria:

  • uncontrolled diabetes , auto immune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients with breast cancer recieving hormonal treatment
evaluation of the effect of hormonal treatment on the cornea
Drug: Hormonal treatment
hormonal treatment for breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear break up time test and shirmer test
Time Frame: 6 months
these tests done before starting treatment and in follow up after recieving treatment to evaluate the lacrimal function and dry eye
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal thickness and endothelium hexagonality
Time Frame: 6 months
Corneal thickness and hesagonality were evaluated before and after treatment with aromatase inhibitors
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Elshimaa abd almateen A mateen, Doctorate, Sohag University
  • Study Chair: alaa mahmoud m mahmoud, mahmoud
  • Study Director: mohamed salah hamed s hamed, Doctorate, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-03-14PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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