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

Sponsor
Fabricio Lopes da Fonseca (Other)
Overall Status
Unknown status
CT.gov ID
NCT01579344
Collaborator
(none)
100
Enrollment
1
Location
2
Arms

Study Details

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 Phase
  • Drug: Radioiodine therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2014

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

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fabricio Lopes da Fonseca, Principal Investigator, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT01579344
    Other Study ID Numbers:
    • 0528/11
    First Posted:
    Apr 17, 2012
    Last Update Posted:
    Apr 18, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Fabricio Lopes da Fonseca, Principal Investigator, University of Sao Paulo
    Iodine Radioisotopes
    Nasolacrimal Duct
    radiation effects
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Lacrimal Apparatus Diseases

    Study Results

    No Results Posted as of Apr 18, 2012