Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2020-11-13
2022-10-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Steroids
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
Prednisone
used to reduce inflammation
No Steroids
Pre-operative Standard of Care
No interventions assigned to this group
Interventions
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Prednisone
used to reduce inflammation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Dawn K Elfenbein
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Protocol Ver October 2020
Identifier Type: OTHER
Identifier Source: secondary_id
A539711
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/ENDOCRINE
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0209
Identifier Type: -
Identifier Source: org_study_id