Submandibular Gland TumorEarly Phase 1NCT04296266
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
A Early Phase 1 study testing Alda-341 in people with Submandibular Gland Tumor and Parotid Gland Tumor, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Submandibular Gland Tumor, Parotid Gland Tumor
- What is being tested?
- Alda-341
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 21 Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Submandibular Gland Tumor, Parotid Gland Tumor
- Being tested
- Alda-341
- Medical subject headings
- Submandibular Gland Neoplasms, Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alda-341Drug
Also called d-limonene
Dietary supplement d-limonene orally administered as a drug.
| Study group | Role | What they receive |
|---|---|---|
| Alda-341 treatment | Experimental | Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery. Receives: Drug: Alda-341 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Alda-341 in salivary gland tissue using GCMS
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.
Measured: 2 week
Secondary outcomes (1)
Bioavailability of Alda-341 in saliva and blood
Bio availability of Alda-341 in saliva and blood will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startFeb 2016
- Primary completion18 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submandibular Gland TumorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quynh-Thu Le, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296266
- Sponsor's protocol ID
- IRB-32994
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
- ClinicalTrials.gov ID
- NCT04296266
- Acronym / sponsor ID
- IRB-32994
- Conditions
- Submandibular Gland Tumor, Parotid Gland Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alda-341 treatment | Experimental | Drug: Alda-341Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alda-341Also: d-limoneneDietary supplement d-limonene orally administered as a drug. | Drug | Alda-341 treatment |
Primary outcome
Bioavailability of Alda-341 in salivary gland tissue using GCMS
Time frame: 2 week
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.
1 secondary outcome
Bioavailability of Alda-341 in saliva and blood
Time frame: 2 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quynh-Thu Le, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alda-341 in people with Submandibular Gland Tumor and Parotid Gland Tumor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of Alda-341 in salivary gland tissue using GCMS (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.