Hypothyroidism; SurgeryNCT03134976
Wound Complications in Head and Neck Surgery
An observational study of Hypothyroidism; Surgery and Head and Neck Cancer, run by University of Michigan at 1 site in United States.
Trial summary
This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism; Surgery, Head and Neck Cancer, Wound Heal
- What is being tested?
- Levothyroxine
- Type of treatment
- Injection or infusion
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the University of Michigan Department of Otolaryngology- Head and Neck Surgery.
Who may be able to join
- In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the head and neck.
Who cannot join
- Children and vulnerable populations are not eligible for participation. Patients undergoing functional (non cancer related) surgery, patients who have undergone more than 1 course of radiation to the head and neck, patients with a history of thyroid cancer, patients presenting initially with a malignant fistula, patients with previous intolerance or allergy to levothyroxine, and patients without a cancer diagnosis are not eligible. Patients may enroll if they are currently hypothyroid, but will be excluded from the study if thyroid function is not normalized by the time of surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim of this study is to identify risk factors for poor wound healing as well as biologic markers associated with wound related complications in head and neck surgery. Most specifically, this study evaluates the effects of thyroid hormone on wound healing. This study will also evaluate pre-operative labs and comorbidities as well as reconstructive factors, post-operative labs, and other variables associated with wound healing. All interventions regarding wound healing fall under current standards of care and standard practice. Data regarding post-operative wound complications will be collected in a prospective fashion on the variables under study using study-specific datasheets. Data sheet will be entered into a secure database for analysis.
- Conditions
- Hypothyroidism; Surgery, Head and Neck Cancer, Wound Heal, Laryngeal Cancer, Laryngeal Fistula
- Being tested
- Levothyroxine
- Keywords
- Salvage surgery, Head and neck cancer, Wound healing, Hypothyroidism, Levothyroxine
- Medical subject headings
- Hypothyroidism, Head and Neck Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid, Tirosint, Levoxyl, Levothroid
Immediately post-operatively, all patients undergoing laryngectomy will be started on established weight-based dosing of levothyroxine administered intravenously due to the variable enteral absorption in post-operative patients including those on continuous tube feed regimens. Standard enteral dose is 1.6 mcg/kg/day. Eighty percent of this dose (1.3 mcg/kg/day) will be given IV to account for the increased bioavailability of IV levothyroxine compared to enteral levothyroxine. The maximum dose will be 200 mcg/day. Patients previously on levothyroxine at doses lower than the above dose will changed to the aforementioned standard dose. Patients on higher doses of levothyroxine pre-operatively will be maintained on on their current dosing.
| Study group | Role | What they receive |
|---|---|---|
| Salvage Larynx | The first group includes subjects with cancer of the voice box (laryngeal squamous cell carcinoma) that has already been treated by either chemotherapy or radiation. This group will be treated using the standard of care, which includes starting thyroid hormone replacement therapy (levothyroxine) after surgery. Receives: Drug: Levothyroxine | |
| Non-Salvage Larynx | The second group of subjects will consist of patients who have head and neck cancer of sites other than the voice box (larynx) without prior exposure to radiation or chemotherapy who are undergoing flap reconstruction surgery. This group will not be treated with levothyroxine so long as the subject has normal thyroid function. If a subject is hypothyroid, then thyroid hormone replacement will be given as a part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy
Blood will be drawn and analyzed for thyroid stimulating hormone (TSH), free T3, and free T4 levels at specified intervals. Subjects will be monitored for pharyngocutaneous fistula formation.
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 May 2017
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothyroidism; SurgeryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew E. Spector, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134976
- Sponsor's protocol ID
- HUM00124347
- Status last verified
- May 2020
- First submitted
- 20 Apr 2017
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Complications in Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT03134976
- Acronym / sponsor ID
- HUM00124347
- Conditions
- Hypothyroidism; Surgery, Head and Neck Cancer, Wound Heal, Laryngeal Cancer, Laryngeal Fistula
- Keywords
- Salvage surgery, Head and neck cancer, Wound healing, Hypothyroidism, Levothyroxine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim of this study is to identify risk factors for poor wound healing as well as biologic markers associated with wound related complications in head and neck surgery. Most specifically, this study evaluates the effects of thyroid hormone on wound healing. This study will also evaluate pre-operative labs and comorbidities as well as reconstructive factors, post-operative labs, and other variables associated with wound healing. All interventions regarding wound healing fall under current standards of care and standard practice. Data regarding post-operative wound complications will be collected in a prospective fashion on the variables under study using study-specific datasheets. Data sheet will be entered into a secure database for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvage Larynx | – | Drug: LevothyroxineThe first group includes subjects with cancer of the voice box (laryngeal squamous cell carcinoma) that has already been treated by either chemotherapy or radiation. This group will be treated using the standard of care, which includes starting thyroid hormone replacement therapy (levothyroxine) after surgery. |
| Non-Salvage Larynx | – | –The second group of subjects will consist of patients who have head and neck cancer of sites other than the voice box (larynx) without prior exposure to radiation or chemotherapy who are undergoing flap reconstruction surgery. This group will not be treated with levothyroxine so long as the subject has normal thyroid function. If a subject is hypothyroid, then thyroid hormone replacement will be given as a part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the University of Michigan Department of Otolaryngology- Head and Neck Surgery.
Key inclusion criteria (1 listed)
- In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the head and neck.
Key exclusion criteria (1 listed)
- Children and vulnerable populations are not eligible for participation. Patients undergoing functional (non cancer related) surgery, patients who have undergone more than 1 course of radiation to the head and neck, patients with a history of thyroid cancer, patients presenting initially with a malignant fistula, patients with previous intolerance or allergy to levothyroxine, and patients without a cancer diagnosis are not eligible. Patients may enroll if they are currently hypothyroid, but will be excluded from the study if thyroid function is not normalized by the time of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineAlso: Synthroid, Tirosint, Levoxyl, LevothroidImmediately post-operatively, all patients undergoing laryngectomy will be started on established weight-based dosing of levothyroxine administered intravenously due to the variable enteral absorption in post-operative patients including those on continuous tube feed regimens. Standard enteral dose is 1.6 mcg/kg/day. Eighty percent of this dose (1.3 mcg/kg/day) will be given IV to account for the increased bioavailability of IV levothyroxine compared to enteral levothyroxine. The maximum dose will be 200 mcg/day. Patients previously on levothyroxine at doses lower than the above dose will changed to the aforementioned standard dose. Patients on higher doses of levothyroxine pre-operatively will be maintained on on their current dosing. | Drug | Salvage Larynx |
Primary outcome
Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy
Time frame: 30 days post-operatively
Blood will be drawn and analyzed for thyroid stimulating hormone (TSH), free T3, and free T4 levels at specified intervals. Subjects will be monitored for pharyngocutaneous fistula formation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism; Surgery and Head and Neck Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy (time frame: 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.