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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05999630

Collaborator

(none)

100

Enrollment

Arms

51.7

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nasolacrimal Duct Obstruction Thyroid Cancer	Drug: Artificial Tears Methylcellulose	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer

Anticipated Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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)	Drug: Artificial Tears Methylcellulose Participants will self-administer the artificial tears according to the schedule.
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.

Arm

Intervention/Treatment

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)

Drug: Artificial Tears Methylcellulose

Participants will self-administer the artificial tears according to the schedule.

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.

Outcome Measures

Primary Outcome Measures

Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO) [2 years]
The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Radio-iodine therapy for thyroid cancer
Radioiodine therapy ≥150 mCi
Age 18 or older

Exclusion Criteria:

Use of eye drops, other than artificial tears
History of periocular trauma with tear duct involvement/lacrimal gland trauma
History of lacrimal drainage disease: canaliculitis, dacryocystitis
Prior radiotherapy
Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
Nasolacrimal duct obstruction at baseline