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Trial Title:
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated with Radioactive Iodine for Thyroid Cancer
NCT ID:
NCT05999630
Condition:
Nasolacrimal Duct Obstruction
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Lacrimal Duct Obstruction
Thyroid Diseases
Lubricant Eye Drops
Conditions: Keywords:
Nasolacrimal Duct Obstruction
Artificial Tears
Thyroid Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Artificial Tears Methylcellulose
Description:
Participants will self-administer the artificial tears according to the schedule.
Arm group label:
Experimental Arm (Artificial Tears)
Summary:
The association of radioiodine therapy for the treatment of thyroid cancer with
nasolacrimal duct obstruction has been well documented in the medical literature. Prior
case reports have documented radioactive iodine detection in the tears of patients
following radioiodine therapy. It is possible that radioactive uptake by the cells in the
lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the
tear duct over time. A recent study has shown that the administration of artificial tears
decreases the level of detectable radioiodine in the tears of patients undergoing
radioiodine therapy for thyroid cancer. The purpose of this study will be to assess
whether administering tears after radioactive iodine therapy for thyroid cancer decreases
the incidence of nasolacrimal duct obstruction in the two years following radioactive
iodine treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Radio-iodine therapy for thyroid cancer
2. Radioiodine therapy ≥150 mCi
3. Age 18 or older
Exclusion Criteria:
1. Use of eye drops, other than artificial tears
2. History of periocular trauma with tear duct involvement/lacrimal gland trauma
3. History of lacrimal drainage disease: canaliculitis, dacryocystitis
4. Prior radiotherapy
5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis
with polyangiitis, chronic lymphocytic leukemia)
7. Nasolacrimal duct obstruction at baseline
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Sobel, MD
Phone:
4152796578
Email:
rachel.k.sobel@vumc.org
Contact backup:
Last name:
Marybeth Carter
Phone:
615-936-1639
Email:
marybeth.l.carter@vumc.org
Start date:
August 21, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Vanderbilt University Medical Center
Agency class:
Other
Source:
Vanderbilt University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999630
