Nutraceutical intervention for Neurofibromatosis 1
Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
This study is testing if taking curcumin and high phenolic extra virgin olive oil can help people with Neurofibromatosis 1 manage their skin tumors better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | selumetinib, chemotherapy, radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05363267 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of curcumin and high phenolic extra virgin olive oil (HP-EVOO) on patients diagnosed with Neurofibromatosis 1 (NF1). Participants will take these interventions twice daily on an empty stomach for up to 12 months, with varying doses of curcumin assigned at enrollment. The study aims to assess the safety and efficacy of these nutraceuticals in managing cutaneous neurofibromas associated with NF1. All participants will follow the same treatment plan, ensuring consistency in the approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Neurofibromatosis 1 and measurable cutaneous neurofibromas.
Not a fit: Patients currently undergoing treatment with specific targeted therapies or those with conditions that may interfere with compliance will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, non-invasive treatment option for managing symptoms of Neurofibromatosis 1.
How similar studies have performed: While the use of nutraceuticals in treating NF1 is an emerging area, similar studies have shown promise in other conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Moertel, MD — Masonic Cancer Center, Univeristy of Minnesota
- Study coordinator: Fullenkamp Fullenkamp
- Email: fulle631@umn.edu
- Phone: 612-625-6125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.