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

Trial ID or NCT#

NCT04296266

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

View on ClinicalTrials.gov