Status:
COMPLETED
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Lead Sponsor:
Stanford University
Conditions:
Submandibular Gland Tumor
Parotid Gland Tumor
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief 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 collect...
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04296266
Start Date
February 1 2016
End Date
December 21 2017
Last Update
March 5 2020
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304