The rationale of this randomized double blind study is to investigate the efficacy of topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. Eye drops containing corticosteroids have an anti-inflammatory effect and may prevent the formation of fibrosis.
Conditions
Interventions
Trade Name: maxidex
Product Name: maxidex
Pharmaceutical Form: Eye drops*
Trade Name: lacrystat
Product Name: lacrystat
Pharmaceutical Form: Eye drops*
Sponsors
UZLeuven Afdeling Oogziekten
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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. 18 years or more no evidence of pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Systemic criteria: o History of treatment with Docetaxel. ? Eye criteria: o Ocular surface, corneal, conjunctival or eyelid disease. o Soft contact lens wearers o 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: 1. Primary acquired nasolacrimal duct obstruction (PANDO) 2. Secondary: o Infection (Herpes simplex, Herpes Zoster, Fungal keratitis, Actinobacter). o Trauma o Drug induced: after topical treatment with idoxuridine, pilocarpine, epinephrine or phospholine jodide. 3. Congenital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses the efficacy of topical eye (maxidex versus lacrystat) treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. ;Secondary Objective: ?Incidence and grading of dacryostenosis in each arm at 3, 6 and 26 weeks. ?Incidence and grading of epiphora in each arm at 3,6,9 and 26 weeks. ?Correlation between Docetaxel concentration in tear fluid at 3 weeks and development and grading of dacryostenosis. ;Primary end point(s): The incidence and grading of dacryostenosis in each arm at 9 weeks. | — |
Countries
Belgium
Outcome results
None listed