Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated with Radioactive Iodine for Thyroid Cancer
Purpose
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.
Conditions
- Nasolacrimal Duct Obstruction
- Thyroid Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Radio-iodine therapy for thyroid cancer 2. Radioiodine therapy ≥150 mCi 3. Age 18 or older
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental Arm (Artificial Tears) |
Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows: Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening) |
|
|
No Intervention No Intervention (No Artificial Tears) |
Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy. |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center