Clinical trial · Interventional
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
NCT04296266CI-TRIAL-00043820completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotid Gland Tumor | Parotid Gland Neoplasm | ALIAS | 0.90 |
| Submandibular Gland Tumor | Submandibular Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alda-341 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alda-341 treatment
- description
- Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.
- interventionNames
- Drug: Alda-341
Primary outcomes (1)
- measure
- Bioavailability of Alda-341 in salivary gland tissue using GCMS
- timeFrame
- 2 week
- description
- 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)
- measure
- Bioavailability of Alda-341 in saliva and blood
- timeFrame
- 2 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.