Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery (LSHT)
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|ClinicalTrials.gov Identifier: NCT02548715|
Recruitment Status : Unknown
Verified September 2015 by Daniel O'Connell, University of Alberta.
Recruitment status was: Not yet recruiting
First Posted : September 14, 2015
Last Update Posted : September 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism Neoplasms Postoperative Complications||Drug: Levothyroxine Drug: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Levothyroxine Treatment of Subclinical Hypothyroidism After Non-thyroid Head and Neck Surgery: A Randomized Controlled Trial|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
Placebo Comparator: Control
Participants administered daily levothyroxine at 1.6mcg/kg to a target normal TSH, measured at 6 weeks after the initiation of therapy
Other Name: Synthroid
- Number of patients with a post-operative wound complication [ Time Frame: 12 weeks post-operatively ]
- Rate of fistula formation
- Rate of wound breakdown
- Rate of post-operative infection
- Rate of flap failure (dehiscence and/or necrosis requiring salvage)
- Number of surviving patients at 6 months [ Time Frame: 6 months post-operatively ]Disease-free, disease-specific, and overall survival
- Number of patients with G-tube [ Time Frame: 12 weeks post-operatively ]
- Quality of life based on EQ-5D7 [ Time Frame: 12 weeks post-operatively ]
- Number of patients with clinical depression [ Time Frame: 12 weeks post-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548715
|Contact: Andre Isaac, MD, BMScfirstname.lastname@example.org|