NCT04542278

Preoperative Steroids in Autoimmune Thyroid Disease

Completed Phase 4 Results posted Last updated 26 December 2023

What this trial tests

Phase 4 trial testing Prednisone in Thyroid Diseases in 30 participants. Completed in 4 October 2022.

Timeline

13 November 2020

Primary endpoint
4 October 2022

4 October 2022

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	13 November 2020
Primary completion	4 October 2022
Estimated completion	4 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Prednisone (prednisone) — full drug profile →

Conditions studied

• Thyroid Diseases — all drugs for Thyroid Diseases →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Thyroid Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Thyroid Difficulty Scale Score Primary · surgery occurs up to 4 weeks, data collected a conclusion of operation

The surgeon will fill out the "Thyroid Difficulty Scale" at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery

Group	Value	95% CI
Steroids	9.8	± 3.8
No Steroids	9.75	± 4.0

Percent Change From Baseline Mean in Autoantibody Levels Primary · baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

Autoantibodies that may be positive include: Thyroglobulin Antibody \[TgAb\], Thyroid peroxidase antibody \[TPO\], Thyroid Stimulating Ig antibody \[TSI\], and/or Thyrotropin Receptor antibody \[TRAb\]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1.

surgery to 2 weeks post op

Group	Value	95% CI
Steroids	0.81	± 0.8
No Steroids	0.78	± 0.24

surgery to 6 weeks post-op

Group	Value	95% CI
Steroids	0.43	± 0.23
No Steroids	0.54	± 0.28

surgery to 6 months post-op

Group	Value	95% CI
Steroids	0.12	± 0.04
No Steroids	0.24	± 0.24

Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) Primary · baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life.

baseline

Group	Value	95% CI
Steroids	39.4	± 11
No Steroids	35.3	± 17.6

6 weeks post-op

Group	Value	95% CI
Steroids	46.7	± 15.7
No Steroids	38.6	± 19.3

6 months post-op

Group	Value	95% CI
Steroids	43.4	± 16.4
No Steroids	40.3	± 22.5

Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) Primary · baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life.

baseline

Group	Value	95% CI
Steroids	41.5	± 10.4
No Steroids	43.2	± 18.1

6 weeks post-op

Group	Value	95% CI
Steroids	47.4	± 14.4
No Steroids	42.7	± 20.9

6 months post-op

Group	Value	95% CI
Steroids	50.2	± 15.8
No Steroids	44.2	± 24.2

Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score Primary · baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life.

Baseline

Group	Value	95% CI
Steroids	2.03	1.17 – 3.25
No Steroids	1.95	0.67 – 2.93

6 weeks post-op

Group	Value	95% CI
Steroids	1.47	0.50 – 2.83
No Steroids	1.05	0.36 – 2.14

6 months post-op

Group	Value	95% CI
Steroids	1.29	0.33 – 2.89
No Steroids	0.99	0.21 – 2.14

Surgical Complications: Parathyroid Hormone (PTH) Level Secondary · immediately after surgery (baseline for all participants)

PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70.

Group	Value	95% CI
Steroids	52	± 43
No Steroids	38	± 30

Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury Secondary · up to 4 weeks (Post Operative Day 1)

Group	Value	95% CI
Steroids	2
No Steroids	2

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 6 months post-operatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Steroids

Serious: 0/14 (0%)

Deaths: 0/14

No Steroids

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (8 terms — click to expand)

Reaction	System	Steroids	No Steroids
insomnia	Psychiatric disorders	—	—
mood changes	Psychiatric disorders	—	—
Gastrointestinal Upset	Gastrointestinal disorders	—	—
increased appetite	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Nerve Injury	Injury, poisoning and procedural complications	—	—
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—

Data from ClinicalTrials.gov NCT04542278 adverse events section.

Sponsor's own description

This pilot project will randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. It will enroll 30 participants who will each be on study for up to 7 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medical Applications of Molecular Biotechnologies in the Context of Hashimoto's Thyroiditis.
   Trovato M, Valenti A. · · 2023 · cited 1× · PMID 37371008 · DOI 10.3390/diagnostics13122114