Effect of Octreotide on Saliva

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.

Detailed Description
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This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.

Official Title
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Effect of Octreotide on Saliva

Conditions
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Healthy

Intervention / Treatment
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* Drug: Octreotide 1 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults between the ages of 18-40 years old Healthy volunteer who is willing to undergo research activities Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Pregnant or nursing women Children under the age of 18 or adults over 40 Complaint of oral symptoms (self-reported) Medical condition affecting saliva (e.g. Sjogren's) History of head/neck radiation Medication that might affect saliva (e.g. Proton Pump Inhibitors) Known allergy to Octreotide Non-English speaking Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteer<br>Octreotide, 100 mcg (1 ml) s.c. | Drug: Octreotide 1 MG/ML<br>* 100 mcg (1 ml) of Octreotide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the change of saliva proteomes of subjects pre-octreotide treatment | Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source | Day 1 pre-treatment | 
| To quantify the change of saliva proteomes of subjects post-octreotide treatment | Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source | Day 1 post-treatment |