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NCT05363267 | Recruiting | Neurofibromatosis 1

NF-1, Nutraceutical Intervention
Sponsor:

Masonic Cancer Center, University of Minnesota

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.

Condition or disease

Neurofibromatosis 1

Intervention/treatment

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

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 18 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025
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)
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
NF-1, Nutraceutical Intervention

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NF-1, Nutraceutical Intervention

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Locations

Recruiting

United States, Minnesota

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455