Preoperative Corticosteroids in Autoimmune Thyroid Disease

Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

Study Overview

• Status: Recruiting
• Conditions: Graves Disease; Hashimoto Disease
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexandria McDow, MD; Phone Number: 317-944-4377; Email: amcdow@iu.edu
• Study Contact Backup: Name: Hannah Allison, MA; Email: hralliso@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Methodist Hospital
      • Contact: Robin Gardiner
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health University Hospital
      • Contact: Robin Gardiner
    • Indianapolis, Indiana, United States, 46032
      • Recruiting
      • IU Health North Hospital
      • Contact: Robin Gardiner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

• Exclusion Criteria:

  • Pediatric patients < 18
  • Prior treatment with RAI
  • Prior neck surgeries
  • Known diagnosis of thyroid cancer
  • Diabetic patients on medications
  • A history of adverse reactions to corticosteroids.
  • Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Steroids; Will be given pre-operative corticosteroid regimen	Drug: Dexamethasone; Will take Dexamethasone pre-operatively
Placebo Comparator: placebo; Will be given Placebo	Drug: Placebo; Will take Placebo pre-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid difficulty Scale score	This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.	Day of Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tg	Tg, 1.3-31.8 ng/mL;	through study completion, an average of 6 months
TgAB	TgAB, 0-4.0 IU/mL;	through study completion, an average of 6 months
TPO	TPO AB 0-9.0 IU/mL;	through study completion, an average of 6 months
TSI	TSI 0-0.54 IU/L;	through study completion, an average of 6 months
TRAb	TRAb 0-1.75 IU/L	through study completion, an average of 6 months
ThyPRO	0 points (best outcome) - 340 points (worst outcome)	through study completion, an average of 6 months
Change in blood flow / vascularity	The surgeon will use ultrasound to assess the vascularity of the surgical area. Scoring is dependent on thyroid gland size, whether there is substernal extension, and the level of vascularity. The minimum score (2) indicates normal vascularity and normal gland size with no substernal extension. The maximum score (11) indicates extensive vascularity and large gland size with substernal extension.	Pre-operative visit and Day of Surgery
Surgical complication of transient hypocalcemia	Number of subjects with transient hypocalcemia (calcium <8.5)	Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypocalcemia	Number of subjects with permanent hypocalcemia (calcium <8.5)	through study completion, or 6 months
Surgical complication of transient hypoparathyroidism	Number of subjects with Post-op PTH <10	Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypoparathyroidism	Number of subjects with Post-op PTH <10	through study completion, or 6 months
Surgical complication of recurrent laryngeal nerve palsy	Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy	Two weeks post-operative and six-weeks post-operative, if clinically indicated
Change in SF-20 at 6 weeks	score ranges from 0 to 100, higher scores indicate better functioning or quality of life	Six weeks post-operative
Change in SF-20 at 6 months	score ranges from 0 to 100, higher scores indicate better functioning or quality of life	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Alexandria McDow, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Graves Disease; Hashimoto Disease; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 10009 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes