Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery
Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
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.