NF-1, Nutraceutical Intervention

NCT05363267 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 2021LS032
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis 1

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (6)

• 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 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 determine preliminary efficacy of the intervention

  End of treatment (12 months)

Study Arms (1)

Curcumin with high phenolic extra virgin olive oil (HP-EVOO)

EXPERIMENTAL

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)

Interventions

curcumin, high phenolic extra virgin olive oil (HP-EVOO) DIETARY_SUPPLEMENT

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

Also known as: curcumin, high phenolic extra virgin olive oil (HP-EVOO)

Curcumin with high phenolic extra virgin olive oil (HP-EVOO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Christopher Moertel, MD

  Masonic Cancer Center, Univeristy of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 5, 2022
• Study Start: July 6, 2022
• Primary Completion: September 2, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)