NF-1, Nutraceutical Intervention

Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)

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 Overview

• Status: Active, not recruiting
• Conditions: Neurofibromatosis 1
• Intervention / Treatment: Dietary supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Dietary supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO); identical for all participants with the exception of the curcumin dose level Dose 1: 1000 mg Curcumin daily dose with 1 capsule and 25 ml HP-EVOO volume at morning and night Dose 2: 2000 mg Curcumin daily dose with 2 capsules and 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules and 25 ml HP-EVOO volume at morning and night; Other Names: curcumin; high phenolic extra virgin olive oil (HP-EVOO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	End of treatment (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the toxicities associated with the planned intervention	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.	4 weeks after 1st dose of curcumin
To evaluate the effect of the intervention on BMI	The BMI will be measures across dose level group 95% confidence intervals.	End of Treatment (12 months)
To evaluate the effect of the intervention on lipid panel	The lipid panel will be measures across dose level group 95% confidence intervals.	End of Treatment (12 months)
To assess the effect of the intervention on quality of life	Focused on skin related morbidity and pain will be evaluated using the average and range of SkinDex scale (0-100)	End of treatment (12 months)
To determine preliminary efficacy of the intervention	Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)	End of treatment (12 months)
To identify issues with compliance to the planned intervention	Incidence of study deviations	End of treatment (12 months)

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Clay Hoerig, MD, Masonic Cancer Center, Univeristy of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): September 2, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neoplasms by Histologic Type; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Heredodegenerative Disorders, Nervous System; Nerve Sheath Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Neurofibroma; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurofibromatoses; Neurofibromatosis 1; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Diarylheptanoids; Heptanes; Alkanes; Catechols; Phenols; Benzene Derivatives; Curcumin
• Other Study ID Numbers: 2021LS032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No