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

NCT01579344 | Unknown DMC

• 1 other identifier: 0528/11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lacrimal Apparatus Disease

Keywords

Iodine Radioisotopes; Nasolacrimal Duct; radiation effects

Study Arms (2)

Thyroid carcinoma, Radioactive iodine therapy

ACTIVE COMPARATOR

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

Drug: Radioiodine therapy

Thyroid carcinoma, without radioactive iodine therapy

NO INTERVENTION

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

Interventions

Radioiodine therapy DRUG

Radioiodine therapy with NaI131

Thyroid carcinoma, Radioactive iodine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thyroid carcinoma
• Previous thyroidectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabricio Lopes da Fonseca: lead

Study Sites (1)

University of Sao Paulo; Ophthalmology Department

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Suzana Matayoshi, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2012
• First Posted: April 17, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Last Updated: April 18, 2012

Record last verified: 2012-04

Locations

BR (1)