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OpenTrials
Active, Not Recruiting

NCT Number: NCT05363267

NF-1, Nutraceutical Intervention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neurofibromatosis 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurocutaneous Syndromes Neurodegenerative Diseases Neurofibroma Neurofibromatoses Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: curcumin, high phenolic extra virgin olive oil (HP-EVOO)

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.

    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

  1. Characterize the toxicities associated with the planned intervention

    Time frame: 4 weeks after 1st dose of curcumin

    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.

  2. To evaluate the effect of the intervention on BMI

    Time frame: End of Treatment (12 months)

    The BMI will be measures across dose level group 95% confidence intervals.

  3. To evaluate the effect of the intervention on lipid panel

    Time frame: End of Treatment (12 months)

    The lipid panel will be measures across dose level group 95% confidence intervals.

  4. To assess the effect of the intervention on quality of life

    Time frame: End of treatment (12 months)

    Focused on skin related morbidity and pain will be evaluated using the average and range of SkinDex scale (0-100)

  5. To determine preliminary efficacy of the intervention

    Time frame: End of treatment (12 months)

    Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)

  6. To identify issues with compliance to the planned intervention

    Time frame: End of treatment (12 months)

    Incidence of study deviations

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 5, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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