Phase 4
N=30
Preoperative Steroids in Autoimmune Thyroid Disease
Thyroid Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04542278 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Thyroid Difficulty Scale Score — 9.8; 9.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thyroid Difficulty Scale Score |
9.8; 9.75 | — |
| PRIMARY Percent Change From Baseline Mean in Autoantibody Levels |
0.81; 0.78; 0.43; 0.54; 0.12; 0.24 | — |
| PRIMARY Change in Antibody-mediated Cytokine Levels |
— | — |
| PRIMARY Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) |
39.4; 35.3; 46.7; 38.6; 43.4; 40.3 | — |
| PRIMARY Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) |
41.5; 43.2; 47.4; 42.7; 50.2; 44.2 | — |
| PRIMARY Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score |
2.03; 1.95; 1.47; 1.05; 1.29; 0.99 | — |
| SECONDARY Ultrasound Doppler Quantification of Blood Flow |
— | — |
| SECONDARY Surgical Complications: Parathyroid Hormone (PTH) Level |
52; 38 | — |
| SECONDARY Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury |
2; 2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04542278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.