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

Lacrimal Apparatus Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01579344
• Other study ID #: 0528/11
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 15, 2012
• Last updated: April 16, 2012
• Start date: January 2012

Study information

• Verified date: April 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lacrimal Apparatus Disease
• Lacrimal Apparatus Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Radioiodine therapy
Radioiodine therapy with NaI131

Locations

Country	Name	City	State
Brazil	University of Sao Paulo; Ophthalmology Department	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Fabricio Lopes da Fonseca

Country where clinical trial is conducted

Brazil,