Effect of Octreotide on Saliva

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2020-02-26

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Volunteer

Octreotide, 100 mcg (1 ml) s.c.

Group Type OTHER

Octreotide 1 MG/ML

Intervention Type DRUG

100 mcg (1 ml) of Octreotide

Interventions

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Octreotide 1 MG/ML

100 mcg (1 ml) of Octreotide

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes