Effect of Octreotide on Saliva

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05340192
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Octreotide 1 MG/ML	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Other
• Official Title: Effect of Octreotide on Saliva
• Actual Study Start Date: Sep 24, 2019
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy Volunteer Octreotide, 100 mcg (1 ml) s.c.	Drug: Octreotide 1 MG/ML; 100 mcg (1 ml) of Octreotide

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Walter Lee, MD, MHS, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05340192
• Other Study ID Numbers: Pro00100579
• First Posted: Apr 22, 2022
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Octreotide

Study Results

No Results Posted as of Apr 22, 2022