Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06455371

Patient-centered Decision Support Tool for Levothyroxine Dosage 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

On this page

Sponsors

U

University Hospital of North Norway

Lead Sponsor

S

SINTEF Health Research

Collaborating Sponsor

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 DST's 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Total or completion thyroidectomy for differentiated thyroid cancer or benign thyroid nodules at Norwegian hospitals
Not Eligible

You will not qualify if you...

  • Anaplastic thyroid cancer
  • Thyroid cancer with distant metastasis
  • Graves disease
  • Toxic nodules
  • Pregnancy

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 3 locations

1

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

2

Oslo University Hospital

Oslo, Norway

Actively Recruiting

3

University Hospital of North Norway

Tromsø, Norway, 9010

Actively Recruiting

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Research Team

V

Vegard Brun, PhD

S

Solveig Brun, cand.med

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy.

Vegard Heimly Brun, Amund H Eriksen, Ruth Selseth...

https://pubmed.ncbi.nlm.nih.gov/33980057

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...

https://pubmed.ncbi.nlm.nih.gov/41857858