Preoperative Steroids in Autoimmune Thyroid Disease

NCT04542278 | Completed Phase 4 Results FDA Drug

• 4 other identifiers: 2020-0209Protocol Ver October 2020A539711SMPH/SURGERY/ENDOCRINE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Diseases

Keywords

Autoimmune disease; Graves' Disease; Hashimoto's Thyroiditis

Outcome Measures

Primary Outcomes (6)

• Thyroid Difficulty Scale Score

  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

  surgery occurs up to 4 weeks, data collected a conclusion of operation

• Percent Change From Baseline Mean in Autoantibody Levels

  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.

  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)

• Change in Antibody-mediated Cytokine Levels

  Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex. Cytokines that have been implicated in other autoimmune disease include: IFN-gamma (BR29), IL-6 (BR13), IL-10 (BR22), IL-13 (BR47), IL-15 (BR63), IL-17A (BR42), and VEGF-C (BR38).

  baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1), up to 6 weeks (2 weeks post-op), up to 30 weeks (6 months post-op)

• Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)

  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 (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

• Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)

  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 (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

• Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score

  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 (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

Secondary Outcomes (3)

• Ultrasound Doppler Quantification of Blood Flow

  baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1)

• Surgical Complications: Parathyroid Hormone (PTH) Level

  immediately after surgery (baseline for all participants)

• Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury

  up to 4 weeks (Post Operative Day 1)

Study Arms (2)

Steroids

ACTIVE COMPARATOR

Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care

Drug: Prednisone

No Steroids

NO INTERVENTION

Pre-operative Standard of Care

Interventions

Prednisone DRUG

used to reduce inflammation

Also known as: steroid drug

Steroids

Eligibility Criteria

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

You may qualify if:

• Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (Thyroglobulin Antibody \[TgAb\], Thyroid peroxidase antibody \[TPO\], Thyroid Stimulating Ig antibody \[TSI\], and/or Thyrotropin Receptor antibody \[TRAb\]).
• Participants will be invited to join the study after the decision has been made to proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid disease.

You may not qualify if:

• Pediatric patients \< 18
• Prior treatment with radioactive iodine (RAI)
• Known diagnosis of thyroid cancer
• Diabetic patients.
• Patients on any immunosuppressive regiment (such as organ transplant patients or patients treated for other autoimmune condition)
• Pregnant patients.
• Patients being treated for active infection.
• Any patient for whom the surgeon feels steroids would provide a clear benefit (ie. Extremely high auto-antibody levels with a very large, inflamed thyroid gland) will be treated according to the clinical judgement of the surgeon. If a surgeon feels steroids are indicated and prescribes them, the patient will not be eligible for the trial.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Thyroid Diseases; Autoimmune Diseases; Graves Disease; Hashimoto Disease

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Immune System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Thyroiditis, Autoimmune; Thyroiditis

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dawn Elfenbein, MD, MPH, FACS
• Organization: University of Wisconsin - Madison School of Medicine and Public Health

elfenbein@surgery.wisc.edu

(608) 263-1387

Study Officials

• Dawn K Elfenbein

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled pilot study

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: November 13, 2020
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)