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Artificial Tears for Blocked Tear Duct After Thyroid Cancer Treatment

Phase 3

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radioiodine therapy ≥150 mCi

Radio-iodine therapy for thyroid cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study if using artificial tears after radioactive iodine therapy for thyroid cancer reduces the chance of tear duct blockage.

Who is the study for?

This trial is for adults over 18 who are undergoing radio-iodine therapy for thyroid cancer with a dose of at least 150 mCi. It's not suitable for those with existing tear duct blockage, use of eye drops other than artificial tears, history of trauma or disease affecting the tear ducts, prior radiation treatments, chemotherapy drug usage, or conditions that cause narrow tear ducts.Check my eligibility

What is being tested?

The study tests if using artificial tears after radioactive iodine treatment can prevent blocked tear ducts in thyroid cancer patients. Researchers believe that these tears might reduce inflammation and fibrosis caused by radioactivity in the nasolacrimal duct over two years.See study design

What are the potential side effects?

Artificial tears are generally safe but may occasionally cause mild irritation or discomfort in the eyes. Since they're used to manage dryness and protect against blockages here, significant side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received radioiodine therapy of 150 mCi or more.

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I have received radio-iodine therapy for thyroid cancer.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm (Artificial Tears)Experimental Treatment1 Intervention

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)

Group II: No Intervention (No Artificial Tears)Active Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,093 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Experimental Arm (Artificial Tears) endanger the health of individuals?

"We rate the security of Experimental Arm (Artificial Tears) as 3 due to data from Phase 3 trials that suggest efficacy and extensive evidence for safety."

Answered by AI

Is this research currently recruiting participants?

"Data hosted on clinicaltrials.gov reveals this ongoing trial is recruiting participants for its research agenda, having first been introduced to the public on August 21st 2023 and most recently updated October 16th of the same year."

Answered by AI

What is the current size of this research project's subject pool?

"Affirmative, according to the data posted on clinicaltrials.gov, this medical experiment is presently recruiting participants. The trial was initially uploaded on August 21st 2023 and last refreshed by October 16th 2023 with a goal of securing 100 individuals at 1 venue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rachel Sobel 2023. "Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999630.

All > Thyroid Cancer