Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-04 @ 4:52 AM
Study NCT ID:
NCT04296266
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013365', 'term': 'Submandibular Gland Neoplasms'}, {'id': 'D010307', 'term': 'Parotid Neoplasms'}], 'ancestors': [{'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D013364', 'term': 'Submandibular Gland Diseases'}, {'id': 'D010305', 'term': 'Parotid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077222', 'term': 'Limonene'}], 'ancestors': [{'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Bioavailability of Alda-341 in saliva and blood', 'timeFrame': '2 week', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Submandibular Gland Tumor', 'Parotid Gland Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement.\n\nSalivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.', 'detailedDescription': 'Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.\n\nSecondary Objective: To determine the bioavailability of Alda-341 in saliva and blood'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor\n* Ability to adhere to study visit schedule and other protocol requirements\n* Operable candidate base on the surgeon's note\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Nursing or pregnant\n* Diagnosis of kidney disease, history of renal disease with creatinine \\> 1.5 mg/dL, or currently on dialysis\n* Diagnosis of end stage liver disease\n* Any unstable medical condition\n* Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement\n* Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement"}, 'identificationModule': {'nctId': 'NCT04296266', 'briefTitle': 'Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery', 'orgStudyIdInfo': {'id': 'IRB-32994'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Alda-341', 'type': 'DRUG', 'otherNames': ['d-limonene'], 'description': 'Dietary supplement d-limonene orally administered as a drug.', 'armGroupLabels': ['Alda-341 treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Quynh-Thu Le, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}