Skip to main content
OpenTrials
Completed

NCT Number: NCT05340192

Effect of Octreotide on Saliva

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Octreotide 1 MG/ML

Drug

100 mcg (1 ml) of Octreotide

Primary outcomes

  1. To quantify the change of saliva proteomes of subjects pre-octreotide treatment

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.