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A Double Blind Interventional Study of the Efficacy of Topical Eye Treatment in the Prevention of Docetaxel Induced Dacryostenosis


Phase 1
18 Years
N/A
Not Enrolling
Both
Epiphora

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Trial Information

A Double Blind Interventional Study of the Efficacy of Topical Eye Treatment in the Prevention of Docetaxel Induced Dacryostenosis


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.

- Age > 18 y

Exclusion Criteria:

- 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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence of dacryostenosis

Outcome Time Frame:

20 weeks

Safety Issue:

No

Principal Investigator

Ilse Mombaerts, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

UZL OFT-ML 3386

NCT ID:

NCT00266838

Start Date:

July 2006

Completion Date:

May 2009

Related Keywords:

  • Epiphora
  • Lacrimal Obstruction
  • Epiphora
  • Lacrimal Apparatus Diseases

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