Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Curcumin with high phenolic extra virgin olive oil (HP-EVOO)
Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.
Intervention: curcumin, high phenolic extra virgin olive oil (HP-EVOO) (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Time Frame: End of treatment (12 months)
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).
Secondary Outcomes
- Characterize the toxicities associated with the planned intervention(4 weeks after 1st dose of curcumin)
- To evaluate the effect of the intervention on BMI(End of Treatment (12 months))
- To determine preliminary efficacy of the intervention(End of treatment (12 months))
- To evaluate the effect of the intervention on lipid panel(End of Treatment (12 months))
- To assess the effect of the intervention on quality of life(End of treatment (12 months))
- To identify issues with compliance to the planned intervention(End of treatment (12 months))