Could a lower dose of thyroid hormone be just as effective for advanced cancer?
NCT ID NCT06790589
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two strategies for using levothyroxine to suppress TSH in patients with advanced thyroid cancer that cannot be fully removed. The standard approach keeps TSH very low (below 0.1), but this can cause side effects. The trial will test if a slightly higher TSH target (0.1 to 0.5) is just as safe and effective at preventing cancer progression. About 70 adults in Alberta will participate, and the main goal is to see how many are alive without their cancer getting worse after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Levothyroxine (Synthroid) oral tablet
- What this could lead to
- If successful, this could show that a less strict TSH target is just as effective, reducing side effects like heart problems and bone loss for patients.
- What could go wrong
- This is a small, early-phase study (70 participants) that may not prove non-inferiority. The results may not apply to all thyroid cancer types or stages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Minimum age of 18 years, with no upper limit of age. 2. ECOG 0-2 3. Patients must be capable of providing consent to enrollment and willing to comply with study treatment and follow-up. 4. Diagnosis of differentiated thyroid cancer (including papillary, follicular, oncocytic, and poorly differentiated subtypes) with advanced structural disease (defined as unresectable persistent/ recurrent locoregional disease and/or distant metastases). 5. Residence within Alberta and referral to the Cross Cancer Institute in Edmonton, for consideration of anticancer therapy and/or follow-up. 6. Absence of any condition hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study. 7. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those resulting in low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient. 8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40 mIU/mL to confirm menopause. 9. Females must not be breastfeeding (timeframe: during study treatment period and for a period of 30 days after the last dose of the study drug). 10. Ability to obtain sufficient thyroid cancer tissue to conduct baseline NGS testing (could be fresh or archived tissue). Exclusion Criteria: 1. Recent acute coronary event (within 6 months of randomization). 2. History of atrial fibrillation. 3. Known hypersensitivity to levothyroxine. \- Treatment with other investigational drugs within 30 days prior to randomization. 4. History of fragility fractures or established diagnosis of osteoporosis. * Prior treatment with levothyroxine before study entry at any dose and with any TSH target is not an exclusion criterion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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