Skip to main content
OpenTrials
Completed

NCT Number: NCT04296266

Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery

The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement.

Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Submandibular Gland Tumor Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Parotid Gland Tumor Parotid Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases Submandibular Gland Diseases Submandibular Gland Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Stanford, California, 94304, United States

About this study

Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.

Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor
  • Ability to adhere to study visit schedule and other protocol requirements
  • Operable candidate base on the surgeon's note
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Nursing or pregnant
  • Diagnosis of kidney disease, history of renal disease with creatinine > 1.5 mg/dL, or currently on dialysis
  • Diagnosis of end stage liver disease
  • Any unstable medical condition
  • Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement
  • Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement

Treatment and study plan

Alda-341

Drug

Dietary supplement d-limonene orally administered as a drug.

Other names: d-limonene

Primary outcomes

  1. Bioavailability of Alda-341 in salivary gland tissue using GCMS

    Time frame: 2 week

    Bio availability of Alda-341 in salivary gland tissue will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.

Secondary outcomes

  1. Bioavailability of Alda-341 in saliva and blood

    Time frame: 2 week

    Bio availability of Alda-341 in saliva and blood will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2020
Registry last updated
Mar 5, 2020

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.

Related clinical trials

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