NF-1, Nutraceutical Intervention

Brief Title

NF-1, Nutraceutical Intervention

Official Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 Characterize the toxicities associated with the planned intervention

Condition

Neurofibromatosis 1

Intervention

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

Study Arms / Comparison Groups

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

Description:  Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Dietary Supplement

Estimated Enrollment

18

Start Date

July 2022

Completion Date

August 2024

Primary Completion Date

August 2023

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christopher Moertel, MD, 612-625-6125, [email protected]

NCT ID

NCT05363267

Organization ID

2021LS032

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota

Study Sponsor

Christopher Moertel, MD, Principal Investigator, Masonic Cancer Center, Univeristy of Minnesota

Verification Date

April 2022