Radioactive Iodine Level, Thyroid Carcinoma
Conditions
Brief summary
The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.
Detailed description
Primary Objective: \- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma. Secondary Objective: \- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.
Interventions
DRUGArtificial Tears
Self-Administered - utilizing eye drop preservative free vials
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Radio-iodine therapy for thyroid cancer * Radioiodine therapy ≥100mCi * Patient wears soft contacts on both eyes
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 * Sarcoid * Granulomatosis with polyangiitis * Chronic lymphocytic leukemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of Radioactive Iodine in Tears | Over a 4 day period | The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preservative Free Artificial Tears Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours.
Artificial Tears: Self-Administered - utilizing eye drop preservative free vials | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Preservative Free Artificial Tears |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Level of Radioactive Iodine in Tears
The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.
Time frame: Over a 4 day period
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preservative Free Artificial Tears | Change in Level of Radioactive Iodine in Tears | 2975.7 Becquerel |