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Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery (LSHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Daniel O'Connell, University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Neoplasms Postoperative Complications Drug: Levothyroxine Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Arm Intervention/treatment
Placebo Comparator: Control
Daily placebo
Drug: Placebo
Experimental: Treatment
Participants administered daily levothyroxine at 1.6mcg/kg to a target normal TSH, measured at 6 weeks after the initiation of therapy
Drug: Levothyroxine
Other Name: Synthroid

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Number of surviving patients at 6 months [ Time Frame: 6 months post-operatively ]
    Disease-free, disease-specific, and overall survival

  2. Number of patients with G-tube [ Time Frame: 12 weeks post-operatively ]
  3. Quality of life based on EQ-5D7 [ Time Frame: 12 weeks post-operatively ]
  4. Number of patients with clinical depression [ Time Frame: 12 weeks post-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT02548715

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Contact: Andre Isaac, MD, BMSc 7802652556

Sponsors and Collaborators
University of Alberta

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Responsible Party: Daniel O'Connell, Assistant Professor, Division of Otolaryngology-Head & Neck Surgery University of Alberta, University of Alberta Identifier: NCT02548715     History of Changes
Other Study ID Numbers: Pro00043413
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015
Keywords provided by Daniel O'Connell, University of Alberta:
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases