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Low Level Laser Therapy for Autoimmune Thyroiditis

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autoimmune Thyroiditis

Intervention: Low-level laser therapy (Procedure); Non laser ordinary red light (Procedure)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: University of Sao Paulo General Hospital

Official(s) and/or principal investigator(s):
Maria Cristina Chammas, MD, Study Director, Affiliation: University of Sao Paulo General Hospital
Carlos Alberto Buchpiguel, PhD, Study Chair, Affiliation: University of Sao Paulo General Hospital
Danilo B Höfling, MD, Principal Investigator, Affiliation: University of Sao Paulo General Hospital

Overall contact:
Danilo B Höfling, MD, Phone: 55 11 30730405, Email: dbhofling@uol.com.br

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.

Clinical Details

Official title: Long-term Follow-up After Treatment of Chronic Autoimmune Thyroiditis With Low Level Laser

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants with Thyroid Nodules as a Measure of Safety

Secondary outcome: Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: All patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (NCT01129492)

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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.

Locations and Contacts

Danilo B Höfling, MD, Phone: 55 11 30730405, Email: dbhofling@uol.com.br

University of Sao Paulo General Hospital, Radiology Institute, Sao Paulo 05403-000, Brazil; Recruiting
Danilo B Höfling, MD, Phone: 55 11 30730405, Email: dbhofling@uol.com.br
Danilo B Höfling, MD, Principal Investigator

University of Sao Paulo General Hospital, São Paulo, Brazil; Not yet recruiting
Danilo B Höfling, MD, Phone: 55 11 30730405, Email: dbhofling@uol.com.br
Danilo B Höfling, MD, Principal Investigator
Maria Cristina Chammas, MD, Sub-Investigator

Additional Information

Related publications:

Höfling DB, Chavantes MC, Juliano AG, Cerri GG, Knobel M, Yoshimura EM, Chammas MC. Low-level laser in the treatment of patients with hypothyroidism induced by chronic autoimmune thyroiditis: a randomized, placebo-controlled clinical trial. Lasers Med Sci. 2013 May;28(3):743-53. doi: 10.1007/s10103-012-1129-9. Epub 2012 Jun 21.

Höfling DB, Chavantes MC, Juliano AG, Cerri GG, Romão R, Yoshimura EM, Chammas MC. Low-level laser therapy in chronic autoimmune thyroiditis: a pilot study. Lasers Surg Med. 2010 Aug;42(6):589-96. doi: 10.1002/lsm.20941.

Höfling DB, Chavantes MC, Juliano AG, Cerri GG, Knobel M, Yoshimura EM, Chammas MC. Assessment of the effects of low-level laser therapy on the thyroid vascularization of patients with autoimmune hypothyroidism by color Doppler ultrasound. ISRN Endocrinol. 2012;2012:126720. doi: 10.5402/2012/126720. Epub 2012 Dec 17.

Starting date: September 2014
Last updated: September 11, 2014

Page last updated: August 23, 2015

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