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Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Primary Purpose

Lacrimal Apparatus Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radioiodine therapy
Sponsored by
Fabricio Lopes da Fonseca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lacrimal Apparatus Disease focused on measuring Iodine Radioisotopes, Nasolacrimal Duct, radiation effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thyroid carcinoma
  • Previous thyroidectomy

Exclusion Criteria:

  • Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic)
  • Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL
  • Lacrimal gland / ocular trauma
  • Radiation therapy for other diseases or radiotherapy of head and neck
  • Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.

Sites / Locations

  • University of Sao Paulo; Ophthalmology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Thyroid carcinoma, Radioactive iodine therapy

Thyroid carcinoma, without radioactive iodine therapy

Arm Description

50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma undergoing radioactive iodine therapy

50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma not undergone radioactive iodine therapy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2012
Last Updated
April 16, 2012
Sponsor
Fabricio Lopes da Fonseca
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1. Study Identification

Unique Protocol Identification Number
NCT01579344
Brief Title
Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma
Official Title
Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabricio Lopes da Fonseca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature. Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients. It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Apparatus Disease
Keywords
Iodine Radioisotopes, Nasolacrimal Duct, radiation effects

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thyroid carcinoma, Radioactive iodine therapy
Arm Type
Active Comparator
Arm Description
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma undergoing radioactive iodine therapy
Arm Title
Thyroid carcinoma, without radioactive iodine therapy
Arm Type
No Intervention
Arm Description
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma not undergone radioactive iodine therapy
Intervention Type
Drug
Intervention Name(s)
Radioiodine therapy
Intervention Description
Radioiodine therapy with NaI131

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thyroid carcinoma Previous thyroidectomy Exclusion Criteria: Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic) Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL Lacrimal gland / ocular trauma Radiation therapy for other diseases or radiotherapy of head and neck Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzana Matayoshi, Professor
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo; Ophthalmology Department
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

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