NF-1, Nutraceutical Intervention

Last updated: September 9, 2024
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Active - Recruiting

Phase

1

Condition

Warts

Brain Tumor

Treatment

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

Clinical Study ID

NCT05363267
2021LS032
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anystudy-related procedure not part of normal medical care

Exclusion

Exclusion Criteria:

  • Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, othertargeted therapies, chemotherapy or radiation

  • Conditions requiring systemic immunosuppression

  • Swallowing difficulties or strong gag reflex which may interfere with studycompliance

  • Any comorbidities that may affect study participation in the judgement of enrollinginvestigator

  • Psychiatric illness, cognitive challenges, social situations, or other circumstancesthat would limit compliance with study requirements, per judgment of the enrollinginvestigator

  • 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 Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Phase: 1
Study Start date:
July 06, 2022
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

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