Clinical trial NCT05363267: NF-1, Nutraceutical Intervention
Official title: Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neurofibromatosis 1
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: End of treatment (12 months)
Secondary outcomes:
measure: Characterize the toxicities associated with the planned intervention
timeFrame: 4 weeks after 1st dose of curcumin
measure: To evaluate the effect of the intervention on BMI
timeFrame: End of Treatment (12 months)
measure: To evaluate the effect of the intervention on lipid panel
timeFrame: End of Treatment (12 months)
measure: To assess the effect of the intervention on quality of life
timeFrame: End of treatment (12 months)
measure: To determine preliminary efficacy of the intervention
timeFrame: End of treatment (12 months)
measure: To identify issues with compliance to the planned intervention
timeFrame: End of treatment (12 months)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, Univeristy of Minnesota
name: Christopher Moertel, MD
role: PRINCIPAL_INVESTIGATOR
References: