Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer

Vanderbilt University Medical Center

Status and phase: Enrolling; Phase 3

Conditions: Nasolacrimal Duct Obstruction; Thyroid Cancer

Treatments: Drug: Artificial Tears Methylcellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05999630

230845

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Experimental Arm (Artificial Tears)

Experimental group

Description:

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)

Treatment:

Drug: Artificial Tears Methylcellulose

No Intervention (No Artificial Tears)

No Intervention group

Description:

Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.