Breast Neoplasm, Exercise
Conditions
Brief summary
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
Interventions
trastuzumab treatment as the oncoteam advised
Sponsors
Semmelweis University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film break up time | through study completion, an average of 1 year | Zero is equivalent to no stability, very short breaking up time. The more seconds, the longer the time and higher the stability, during the tear film remains healthy and stable . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index | through study completion, an average of 1 year | Zero is equivalent to no pain or discomfort and the higher the points, the more pain and discomfort is detected. Range 0-100. |
Countries
Hungary
Outcome results
None listed