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

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ClinicalTrials.gov Identifier: NCT01579344
Recruitment Status : Unknown
Verified April 2012 by Fabricio Lopes da Fonseca, University of Sao Paulo.
Recruitment status was:  Enrolling by invitation
First Posted : April 17, 2012
Last Update Posted : April 18, 2012
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Lacrimal Apparatus Disease Drug: Radioiodine therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma
Study Start Date : January 2012
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Thyroid carcinoma, Radioactive iodine therapy
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma undergoing radioactive iodine therapy
Drug: Radioiodine therapy
Radioiodine therapy with NaI131
No Intervention: Thyroid carcinoma, without radioactive iodine therapy
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma not undergone radioactive iodine therapy


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579344


Locations
Brazil
University of Sao Paulo; Ophthalmology Department
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
Fabricio Lopes da Fonseca
Investigators
Principal Investigator: Suzana Matayoshi, Professor University of Sao Paulo
More Information

Responsible Party: Fabricio Lopes da Fonseca, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01579344     History of Changes
Other Study ID Numbers: 0528/11
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: April 18, 2012
Last Verified: April 2012

Keywords provided by Fabricio Lopes da Fonseca, University of Sao Paulo:
Iodine Radioisotopes
Nasolacrimal Duct
radiation effects

Additional relevant MeSH terms:
Thyroid Neoplasms
Lacrimal Apparatus Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Eye Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs