WithdrawnPhase 2/3

Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery

0Started 2015-07

Plain-language summary

Patients that require treatment for cancers of the head and neck often require a combination of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common complications, and has been associated with post-operative complications such as wound healing problems, fistula formation, and decreased quality of life and survival. Several studies have examined hypothyroidism after radiation to the head and neck, but few have examined this after non-thyroid head and neck surgery. Head and neck resection is theorized to devascularize the thyroid, thus resulting in post-operative hypothyroidism. Synthroid is a synthetic thyroid hormone often used in cases of patients with proven hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied for over fifty years. Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and is associated with post-operative complications as noted above. Therefore the investigators propose a double blinded randomized controlled trial comparing outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who are given a standardized dose of synthroid treatment versus those treated with placebo. The main outcomes to be examined are post-operative complications (wound healing issues, fistula formation), survival, and quality of life measures.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biopsy proven head and neck cancer, as defined by AJCC staging system * Treated with surgery in Edmonton, Alberta * Treated with curative intent * Diagnosis of sub-clinical hypothyroidism after head and neck surgery (TSH 4-10mIU/L, and free T4 10-24pmol/L) Exclusion Criteria: * Head and neck cancer of the thyroid gland, or other subsite involving the thyroid gland * Underwent previous treatment for a different head and neck cancer * History of radiation therapy and or chemotherapy to the head and neck * History of thyroid disease as follows: * Hypothyroidism * Hyperthyroidism * Autoimmune thyroid disease including Grave's disease and Hashimoto's thyroiditis * History of thyroiditis * History of diabetes mellitus * History of long term steroid usage * History of immunocompromise * History of thyroid surgery * History of ischemic heart disease * Age \>80 * Patients taking a medication that may alter the metabolism or interact with levothyroxine, which they cannot safely stop (see Appendix A).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with a post-operative wound complication

Timeframe: 12 weeks post-operatively

Trial details

NCT IDNCT02548715

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Hypothyroidism trials