Clinical Trial: Prevention of Docetaxel Induced Dacryostenosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind Interventional Study of the Efficacy of Topical Eye Treatment in the Prevention of Docetaxel Induced Dacryostenosis
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 schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye) caused by dacryostenosis.
The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal tears. Direct contact between Docetaxel containing tears and the epithelial lining causes chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the lacrimal outflow system i.e. the lacrimal puncta and canaliculi.
A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube of Jones is required.
To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis.
The rationale of this randomized double blind interventional study is to investigate the efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel
Detailed Summary:
Sponsor: Universitaire Ziekenhuizen Leuven
Current Primary Outcome:
- Incidence of dacryostenosis [ Time Frame: 20 weeks ]
- Grading of dacryostenosis [ Time Frame: 20 weeks ]
Original Primary Outcome:
Current Secondary Outcome: Correlation Docetaxel in lacrimal tear and dacryostenosis [ Time Frame: 20 weeks ]
Original Secondary Outcome:
Information By: Universitaire Ziekenhuizen Leuven
Dates:
Date Received: December 16, 2005
Date Started: July 2006
Date Completion:
Last Updated: June 24, 2010
Last Verified: December 2005
