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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on establishing safety, what does that mean for how much is actually known about whether curcumin and oleocanthal-rich olive oil help with my cutaneous neurofibromas — and should that affect my decision about participating?
2The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new participants — is there any chance I could still get access to these supplements through a similar study or another pathway my doctor knows about?
3Curcumin and olive oil are available over the counter, so is there any reason I shouldn't simply try taking them on my own, or are there specific dosing or interaction concerns that make it important to do this only under medical supervision?
4Would my doctor recommend I pursue any standard-of-care treatments for my cutaneous neurofibromas first before exploring a nutraceutical approach like this one, especially given that the Phase 1 goal is still just establishing safety?
5Are there other NF-1 clinical trials — perhaps in later phases with more safety and effectiveness data — that might be worth considering alongside or instead of this nutraceutical study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Trial details
NCT IDNCT05363267
SponsorMasonic Cancer Center, University of Minnesota