Clinical trial NCT04542278: Preoperative Steroids in Autoimmune Thyroid Disease
Official title: Randomized Controlled Trial of Preoperative Steroids in Autoimmune Thyroid Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Diseases
Keywords: Autoimmune disease
Graves' Disease
Hashimoto's Thyroiditis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled pilot study
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Graves' disease and Hashimoto's thyroiditis are autoimmune conditions affecting the thyroid gland. Surgery to remove the thyroid gland in these patients may be complicated by the inflammatory nature of these diseases. Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been used systematically to reduce inflammation in patients about to undergo surgery.

This is a pilot project that proposes to 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. This could potentially lead to better outcomes for these patients, as well as increased time to recovery and improved quality of life.

This project proposes to administer short quality of life surveys at three time points, as well as draw additional labs to measure inflammation and antibody levels at times when patients will already be getting labs drawn for clinical purposes. The purpose of this study is to generate preliminary data from which a larger, blinded, placebo-controlled trial could be designed.

These specific aims are:

* Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:

  * Difficulty of surgery and rates of surgical complications
  * Serum autoantibody levels
* Longitudinally assess the impact of surgical treatment on QoL in patients with autoimmune thyroid disease

Update: Protocol amendment approved on 10-22-2020: Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees. Cytokine levels are not something typically collected or tracked in the course of clinical care, and may not be relevant. Study can proceed without this aim and will not alter the main outcome measures of antibody levels and difficulty of the operation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Thyroid Difficulty Scale Score
timeFrame: surgery occurs up to 4 weeks, data collected a conclusion of operation
measure: Percent Change From Baseline Mean in Autoantibody Levels
timeFrame: 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)
measure: Change in Antibody-mediated Cytokine Levels
timeFrame: 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)
measure: Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)
timeFrame: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
measure: Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)
timeFrame: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
measure: Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score
timeFrame: 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:
measure: Ultrasound Doppler Quantification of Blood Flow
timeFrame: baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1)
measure: Surgical Complications: Parathyroid Hormone (PTH) Level
timeFrame: immediately after surgery (baseline for all participants)
measure: Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury
timeFrame: up to 4 weeks (Post Operative Day 1)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dawn K Elfenbein
role: PRINCIPAL_INVESTIGATOR
References: