A Study Comparing Early Dosage Adjustment Using a Decision Support Tool Versus Standard Practice for Levothyroxine After Total Thyroidectomy
Led by University Hospital of North Norway · Updated on 2025-09-10
240
Participants Needed
3
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a decision support tool DST designed to help doctors adjust levothyroxine dosage more quickly for patients who have undergone total thyroidectomy. Levothyroxine is a common hormone replacement for people whose thyroid gland is no longer functioning properly. This randomized study compares the DSTs early dosage recommendations with the usual practice of adjusting doses every two months, aiming to see if faster dose optimization improves patient outcomes and work ability.
Participants will be randomly assigned to one of four groups standard clinical practice where dosage is adjusted based on thyroid-stimulating hormone TSH levels every 6-8 weeks, or three experimental groups using different versions of the DST that calculate dosage changes based on blood samples taken within the first two weeks after surgery. The DST uses mathematical models with either 2 or 4 blood samples to recommend dosage adjustments.
Throughout the study, patients will undergo blood tests to measure biochemical targets at 8 weeks, 6 months, 12 months, and up to 18 months after surgery. Patient-reported outcomes will be collected using the ThyPRO39 and RAND-36 questionnaires before surgery and at intervals afterward. Researchers will also monitor patients time to reach the biochemical target, distance from target, and absence from work. The total participation duration includes follow-up assessments up to 18 months post-surgery.
CONDITIONS
Brief Title
Patient-centered Dosage of Levothyroxine
Research Team
V
Vegard Brun, PhD
S
Solveig Brun, cand.med
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Total or completion thyroidectomy for differentiated thyroid cancer or benign thyroid nodules at Norwegian hospitals
You will not qualify if you...
Anaplastic thyroid cancer
Thyroid cancer with distant metastasis
Graves disease
Toxic nodules
Pregnancy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months after surgery
Participants adjust their levothyroxine dose after total thyroidectomy using either standard clinical practice or one of three decision support tool models based on blood samples.
Visits every 6 to 8 weeks for dose adjustment and blood sampling
Follow-up
Duration - Up to 18 months after surgery
Participants are monitored for biochemical targets and patient-reported outcomes up to 18 months after surgery.
Assessments at 2 weeks before surgery, 8 weeks, 2 months, 6 months, 12 months, and 18 months after surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Phase I Study of 177Lu-CTR-FAPI Radioligand Therapy for Thyroid Cancer Evaluating Safety and Effectiveness
Safety and Effectiveness of a New 18F Labeled Fibroblast Activation Protein Probe for Early Tumor Detection
Including Lung, Pancreatic, Neuroendocrine, and Thyroid Cancers
Phase III Study Comparing Preventive Central Neck Dissection Versus No Dissection in Adults with Low-risk Papillary Thyroid Cancer
Study of Thyroid Hormone Treatment With Levothyroxine in Adults on Hemodialysis to Improve Quality of Life and Heart Health
Phase 3 Trial of AL2846 Capsules Versus Placebo for Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer After VEGFR-Targeted Therapy
Phase 2 Study of Avutometinib and Defactinib for Treating RAF Dimer-Driven Radioiodine-Refractory Differentiated and Anaplastic Thyroid Cancer
Comparison of Meaning-Centered Psychotherapy and Cognitive Behavioral Therapy for Mexican Adults with Advanced Cancer
Randomized Study Comparing Online and Offline Follow-up for Adults With Papillary Thyroid Cancer After Surgery
A Phase 23 Study Comparing Oral Armour Thyroid and Synthetic T4 in Adults With Primary Hypothyroidism
Evaluating Safety and Effectiveness of Dose Conversion from Synthetic T4 to Armour Thyroid
Collecting Information on Use of Redifferentiation Medications for Radioactive Iodine-Refractory Thyroid Cancer in Routine Care
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Impact of a patient-centred levothyroxine decision support tool on rapid achievement of target dosage and improved patient outcomes: protocol for a randomised controlled trial.
Solveig Robertsen Konst, Lars Hellemo, Beate Hennie Garcia...