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

• Status: Completed
• Trial end date: 2017-12-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University

Criteria

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