Ophthalmological Examination of Changes Induced by Therapy and Ocular Surface Abnormalities in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
clinical trial
The goal of this clinical trial is to learn if drug trastuzumab works to treat HER2 positive mamma carcinomas without causing dry eye related ocular surface changes in adults. The main questions it aims to answer are:
Does trastuzumab increase the dry eye related subjective symptoms? Does trastuzumab cause increased tear film instability and corneal epithelial staining (Oxford score), and lipid layer deterioration? Is a dose-dependent ocular surface effect identifiable attributable to trastuzumab and their modification by patient age?
Participants will:
Take drug trastuzumab-based chemotherapy based on the decision of the local onco-team.
Visit the clinic once every 3 months for checkups and tests Keep a diary of their ocular symptoms Make ocular examination and measure dry eye related parameters
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received the following anti-HER2 therapies (according to protocol and national guidelines in Hungary at the time) administered either as monotherapy or in combination based on disease characteristics: trastuzumab (alone or in combination with pertuzumab), pertuzumab (in combination with trastuzumab), trastuzumab emtansine (monotherapy), and trastuzumab deruxtecan (monotherapy).
- •General eligibility criteria for anti-HER2 therapy included patients over the age of 18 years, of either sex, with invasive breast cancer showing HER2 overexpression as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH).
排除标准
- •not willing to participate
- •any preexisting ocular disease
- •Eastern Cooperative Oncology Group (ECOG) performance status higher than 2 -inadequate bone marrow, renal, and hepatic function
- •untreated cardiac disease
- •left ventricular ejection fraction (LVEF) of less than 50%.
研究者
Barcsay-Veres Amarilla
MD, PhD senior lecturer
Semmelweis University