Status:
COMPLETED
Prevention of Docetaxel Induced Dacryostenosis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Epiphora
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently used schedule...
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic breast cancer receiving weekly Docetaxel chemotherapy with rest weeks in between at regular time intervals. The timing of rest weeks between cycles is not restricted. Examples of allowed regimens are Docetaxel 36 mg/m2 day 1 and 8 every 3 weeks; day 1, 8, 15 every 4 weeks; day 1, 8, 15, 21, 28, 35, 42, 49 every 10 weeks. Dosing and rest weeks can be further modified depending on the clinical situation, but dose intensity should be at least 60 mg/m2 every 3 weeks during the 9 week treatments for eligibility. Combination with other chemotherapy (such as capecitabine) is allowed.
- Capability to administer eye drops (either by patient or companion).
- Written informed consent.
- Age \> 18 y
Exclusion
- Systemic criteria:
- Previous administration of Docetaxel.
- Pregnancy.
- Eye criteria:
- Ocular surface, corneal, conjunctival or eyelid disease.
- Soft contact lens wearing
- Glaucoma
- Lacrimal criteria:
- Hypersecretion of tears: ocular surface, corneal, conjunctival or eyelid disease.
- Functional blockage of lacrimal drainage without anatomical obstruction (facial nerve palsy, displacement of the lower lacrimal punctum from the lacrimal lake, involutional lower eyelid laxity).
- Anatomical obstruction of lacrimal drainage system:
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00266838
Start Date
July 1 2006
End Date
May 1 2009
Last Update
June 28 2010
Active Locations (1)
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1
Mombaerts
Leuven, Belgium, 3000