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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455371
Other study ID # 547311
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date December 2027

Study information

Verified date June 2024
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date December 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals Exclusion Criteria: - Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Decision support tool
Patients in the intervention groups are given the option to use the decision support tool when adjusting the levothyroxine dose after total thyroidectomy. Levothyroxine therapy is not a part of the intervention, as all patients receive this therapy regardless of study participation.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University Hospital of North Norway Helse Nord, Helseapps, Norinnova, SINTEF Health Research

References & Publications (1)

Brun VH, Eriksen AH, Selseth R, Johansson K, Vik R, Davidsen B, Kaut M, Hellemo L. Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy. Thyroid. 2021 Sep;31(9):1297-1304. doi: 10.1089/thy.2021.0125. Epub 2021 Jun 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients at biochemical target Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy Outcome is measured at 8 weeks, 6 months and 12 months post surgery
Secondary Time to biochemical target Time to biochemical target is reached measured in days. Day 0 is day of surgery Measured at 18 months after surgery
Secondary Distance from biochemical target Distance measured in TSH units. Measured at 8 weeks post surgery
Secondary Patient reported outcome - ThyPRO39 questionnaire Patient reported outcomes measured by the validated questionnaire ThyPRO39. The ThyPRO39 questionnaire consist of 12 scales that covers physical symptoms (goiter, eye symptoms, hypo- and hyperthyroid symptoms), cosmetic appearance, physical, mental and social well-being and function. Each item is rated on a 0-4 scale from 0 = no symptoms/problems to 4 = Severe symptoms/problems. The average score of items in a scale is divided by four and multiplied by 100 to yield thirteen 0-100 scales, with higher scores indicating worse health status.
The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.
Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
Secondary Patient reported outcome - RAND-36 questionnaire Rand-36 is the Norwegian translation of the SF-36 version 1.2. The questionnaire consists of 36 items, grouped into eight multi-item scales that measure physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The scores can also be summarized into two summary scores for overall physical and mental health. Items scores will be transformed to 0-100 point scales (0=worst, 100=best) using the SF-36 scoring algorithm
The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.
Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
Secondary Abscence from work Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry Measured at18 months after surgery
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