NCT06924229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
Last Updated

April 11, 2025

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

March 17, 2025

Last Update Submit

April 4, 2025

Conditions

Braest CancerDry Eye

Keywords

corneal changesbreast cancerhormonal treatment

Outcome Measures

Primary Outcomes (1)

  • tear break up time test and shirmer test

    these tests done before starting treatment and in follow up after recieving treatment to evaluate the lacrimal function and dry eye

    6 months

Secondary Outcomes (1)

  • Corneal thickness and endothelium hexagonality

    6 months

Study Arms (1)

patients with breast cancer recieving hormonal treatment

ACTIVE COMPARATOR

evaluation of the effect of hormonal treatment on the cornea

Drug: Hormonal treatment

Interventions

Hormonal treatmentDRUG

hormonal treatment for breast cancer

patients with breast cancer recieving hormonal treatment

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females diagnosed with breast cancer

You may not qualify if:

  • uncontrolled diabetes , auto immune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

Related Links

MeSH Terms

Conditions

Dry Eye SyndromesBreast Neoplasms

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elshimaa abd almateen A mateen, Doctorate

    Sohag University

    STUDY CHAIR

  • alaa mahmoud m mahmoud

    mahmoud

    STUDY CHAIR

  • mohamed salah hamed s hamed, Doctorate

    Sohag University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 17, 2025

First Posted

April 11, 2025

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 11, 2025

Record last verified: 2024-06

Locations

EG(1)