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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999630
• Other study ID #: 230845
• Status: Recruiting
• Phase: Phase 3
• Start date: August 21, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: Marybeth Carter
• Phone: 615-936-1639
• Email: marybeth.l.carter[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction
• Nasolacrimal Duct Obstruction
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Artificial Tears Methylcellulose
Participants will self-administer the artificial tears according to the schedule.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)	The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.	2 years