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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Fabricio Lopes da Fonseca, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01579344
First received: April 15, 2012
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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 Intervention
Lacrimal Apparatus Disease
Drug: Radioiodine therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 15, 2012
Last Updated: April 16, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Iodine Radioisotopes
Nasolacrimal Duct
radiation effects

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

ClinicalTrials.gov processed this record on July 20, 2014