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

Primary Purpose

Nasolacrimal Duct Obstruction, Thyroid Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Artificial Tears Methylcellulose
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasolacrimal Duct Obstruction focused on measuring Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Arm (Artificial Tears)

No Intervention (No Artificial Tears)

Arm 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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2023
Last Updated
October 16, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05999630
Brief Title
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
Official Title
The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasolacrimal Duct Obstruction, Thyroid Cancer
Keywords
Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm (Artificial Tears)
Arm Type
Experimental
Arm 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)
Arm Title
No Intervention (No Artificial Tears)
Arm Type
No Intervention
Arm Description
Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.
Intervention Type
Drug
Intervention Name(s)
Artificial Tears Methylcellulose
Intervention Description
Participants will self-administer the artificial tears according to the schedule.
Primary Outcome Measure Information:
Title
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
Description
The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marybeth Carter
Phone
615-936-1639
Email
marybeth.l.carter@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Sobel, MD
Phone
415-279-6578
Email
rachel.k.sobel@vumc.org
First Name & Middle Initial & Last Name & Degree
Marybeth Carter
Phone
615-936-1639
Email
marybeth.l.carter@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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