Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 3:52 PM
Study NCT ID:
NCT05363267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NF-1, Nutraceutical Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009456', 'term': 'Neurofibromatosis 1'}], 'ancestors': [{'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to establish the safety and preliminary activity of curcumin and oleocanthal-rich olive oil supplementation in adult NF-1 persons with cutaneous neurofibromas.', 'timeFrame': 'End of treatment (12 months)', 'description': 'The safety of this supplementation will be measured by the incidence of unacceptable/dose limiting toxicity (DLT) as defined any new Grade 2 or greater toxicity (based on CTCAE v 5).'}], 'secondaryOutcomes': [{'measure': 'Characterize the toxicities associated with the planned intervention', 'timeFrame': '4 weeks after 1st dose of curcumin', 'description': 'Incidence of unacceptable/dose limiting toxicity defined as any new ≥Grade 2 toxicity (based on CTCAE v 5) that cannot be attributed to the disease under treatment or other reason.'}, {'measure': 'To evaluate the effect of the intervention on BMI', 'timeFrame': 'End of Treatment (12 months)', 'description': 'The BMI will be measures across dose level group 95% confidence intervals.'}, {'measure': 'To evaluate the effect of the intervention on lipid panel', 'timeFrame': 'End of Treatment (12 months)', 'description': 'The lipid panel will be measures across dose level group 95% confidence intervals.'}, {'measure': 'To assess the effect of the intervention on quality of life', 'timeFrame': 'End of treatment (12 months)', 'description': 'Focused on skin related morbidity and pain will be evaluated using the average and range of SkinDex scale (0-100)'}, {'measure': 'To determine preliminary efficacy of the intervention', 'timeFrame': 'End of treatment (12 months)', 'description': 'Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)'}, {'measure': 'To identify issues with compliance to the planned intervention', 'timeFrame': 'End of treatment (12 months)', 'description': 'Incidence of study deviations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurofibromatosis 1']}, 'descriptionModule': {'briefSummary': 'The treatment plan is identical for all participants with the exception of the curcumin dose level that is assigned at study enrollment. Participants are instructed to take the curcumin and olive oil one after the other (order does not matter) twice a day on an empty stomach ideally 30 minutes before breakfast and dinner.\n\nCurcumin and high phenolic extra virgin olive oil (HP-EVOO) may continue for up to 12 months in the absence of unacceptable side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing\n* Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF\n* Aged 18 years or older at the time of written consent\n* Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care\n\nExclusion Criteria:\n\n* Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation\n* Conditions requiring systemic immunosuppression\n* Swallowing difficulties or strong gag reflex which may interfere with study compliance\n* Any comorbidities that may affect study participation in the judgement of enrolling investigator\n* Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator\n* Treatment with high phenolic olive oil or curcumin within six months of study entry\n* Known pregnancy or anticipated conception during the 1 year study period'}, 'identificationModule': {'nctId': 'NCT05363267', 'briefTitle': 'NF-1, Nutraceutical Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)', 'orgStudyIdInfo': {'id': '2021LS032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curcumin with high phenolic extra virgin olive oil (HP-EVOO)', 'description': 'Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.', 'interventionNames': ['Dietary Supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO)']}], 'interventions': [{'name': 'curcumin, high phenolic extra virgin olive oil (HP-EVOO)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['curcumin', 'high phenolic extra virgin olive oil (HP-EVOO)'], 'description': 'identical for all participants with the exception of the curcumin dose level\n\nDose 1: 1000 mg Curcumin daily dose with 1 capsule of 25 ml HP-EVOO volume at morning and night Dose 1: 2000 mg Curcumin daily dose with 2 capsules of 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules of 25 ml HP-EVOO volume at morning and night', 'armGroupLabels': ['Curcumin with high phenolic extra virgin olive oil (HP-EVOO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Christopher Moertel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, Univeristy of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}