NF-1, Nutraceutical Intervention

University of Minnesota (UMN)

Status and phase: Active, not recruiting; Phase 1

Conditions: Neurofibromatosis 1

Treatments: Dietary Supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05363267

2021LS032

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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