Effect of Octreotide on Saliva

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Octreotide 1 MG/ML

• Registration Number: NCT05340192
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-24
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer	Octreotide 1 MG/ML	Octreotide, 100 mcg (1 ml) s.c.

Primary Outcome Measures

Name	Time	Method
To quantify the change of saliva proteomes of subjects pre-octreotide treatment	Day 1 pre-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
To quantify the change of saliva proteomes of subjects post-octreotide treatment	Day 1 post-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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States