Patient-centered Dosage of Levothyroxine

Thyroid Cancer Clinical Trial

Official title:

Patient-centered Decision Support Tool for Levothyroxine Dosage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455371
• Other study ID #: 547311
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypothyroidism
• Thyroid
• Thyroid Cancer
• Thyroid Diseases

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