The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: administration cord blood based eye drops, standardized to the deliver BDNF..
- Who it may be relevant to
- Registry conditions: Dry Eye. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops
Overview
The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.
Detailed description
Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.
The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.
Interventions
- Drug administration cord blood based eye drops, standardized to the deliver BDNF.
administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells
Primary outcome measures
- Corneal damage measured with National Eye Institute (NEI) score [Time frame: one week before the start of treatment and thirty days after the end of treatment.]
Secondary outcome measures (3)
- Change in discomfort [Time frame: one week before the start of treatment and thirty days after the end of treatment.]
- Change in quality of life [Time frame: one week before the start of treatment and thirty days after the end of treatment.]
- Change in quality of life [Time frame: one week before the start of treatment and thirty days after the end of treatment.]
Eligibility criteria
Inclusion criteria
- age over 18 years
- oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
- signing of informed consent
Exclusion criteria
- Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06830551 · OFTAFONTANA_DED_EGFR-I · F35F22000080001