Brief Title
NF-1, Nutraceutical Intervention
Official Title
Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
Brief Summary
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. Curcumin and high phenolic extra virgin olive oil (HP-EVOO) may continue for up to 12 months in the absence of unacceptable side effects.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Characterize the toxicities associated with the planned intervention
Condition
Neurofibromatosis 1
Intervention
curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
18
Start Date
July 2022
Completion Date
August 2024
Primary Completion Date
August 2023
Eligibility Criteria
Inclusion Criteria: - NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing - Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF - Aged 18 years or older at the time of written consent - Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care Exclusion Criteria: - Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation - Conditions requiring systemic immunosuppression - Swallowing difficulties or strong gag reflex which may interfere with study compliance - Any comorbidities that may affect study participation in the judgement of enrolling investigator - Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator - Treatment with high phenolic olive oil or curcumin within six months of study entry - Known pregnancy or anticipated conception during the 1 year study period
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christopher Moertel, MD, 612-625-6125, [email protected]
Administrative Informations
NCT ID
NCT05363267
Organization ID
2021LS032
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Christopher Moertel, MD, Principal Investigator, Masonic Cancer Center, Univeristy of Minnesota
Verification Date
April 2022