Overview

This trial is active, not recruiting.

Condition autoimmune thyroiditis
Treatments low-level laser therapy, non laser ordinary red light
Phase phase 2/phase 3
Sponsor University of Sao Paulo General Hospital
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date September 2014
End date November 2015
Trial size 43 participants
Trial identifier NCT02240563, CAPPesq 11459

Summary

INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized, placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without nodules on ultrasonography study (US) was conducted from March 2006 to March 2009 (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid vascularization pattern by US. There was also improvement in the thyroid function and reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on the thyroid parenchyma are unknown. Thus, the objective of this study is to perform biochemical tests and thyroid US six years after the clinical trial interventions to evaluate levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature of nodules in the gland and then compare these variables between LLLT and placebo groups. METHODS: This study will include the trial participants performed six years before. The levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US will assess the texture (with particular attention to identifying nodules), echogenicity, volume, as well as vascularization of the gland. The US nodules features, such as dimensions, shape, margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification, internal content, vascularization pattern and resistivity index will be searched. Regional lymph nodes and other characteristics will be also investigated. The USs will be carried out by only one examiner who will be blinded for the previously performed intervention (LILT or placebo). The same investigator will execute a fine needle aspiration (FNA) of patients with thyroid nodules. The cytological analysis of the material collected from the nodules will be undertaken by a pathologist who will be also blinded for the treatment assignments. RESULTS: The following variables will be compared between the two groups: levothyroxine doses, antithyroid antibodies, US parameters, thyroid nodules (if detected) and in this case, the result of their respective FNA.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This group of patients was treated with a continuous wave diode laser device (830 nanometer, infrared) with a beam area of 0.002827 cm2 using the punctual method on the continuous emission mode at an output power of 50 milliwatts and a fluence of 707 Joules/cm2 six years before.
low-level laser therapy Low-power laser therapy
(Placebo Comparator)
This group of patients was treated using the same method and equipment, except that a non laser ordinary red light, an output power of 0.1 Watt and a fluence of 1.41 Joules/cm2 and an irradiance value of 0.0002827 Watts/cm2 (the placebo), indistinguishable from the laser beam, was used. Therefore, the patients were blinded to which treatment they received.
non laser ordinary red light Placebo

Primary Outcomes

Measure
Number of Participants with Thyroid Nodules as a Measure of Safety
time frame: Six Years after Each Patient Treatment

Secondary Outcomes

Measure
Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy
time frame: Six Years after Each Patient Treatment

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

Inclusion Criteria: All patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (NCT01129492) Exclusion Criteria: All patients who have hypothyroidism caused by autoimmune thyroiditis included in the aforementioned trial (NCT01129492) who underwent surgery and/or therapeutic administration of radioiodine for thyroid diseases during the period between the initial assessment of patients up to the present study.

Additional Information

Official title Long-term Follow-up After Treatment of Chronic Autoimmune Thyroiditis With Low Level Laser
Principal investigator Danilo B Höfling, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.