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

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)