NF-1, Nutraceutical Intervention

Phase 1Active Not RecruitingNCT05363267

Masonic Cancer Center, University of Minnesota23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neurofibromatosis 1

Interventions

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

identical for all participants with the exception of the curcumin dose level Dose 1: 1000 mg Curcumin daily dose with 1 capsule and 25 ml HP-EVOO volume at morning and night Dose 2: 2000 mg Curcumin daily dose with 2 capsules and 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules and 25 ml HP-EVOO volume at morning and night

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

The safety of this supplementation will be measured by the incidence of unacceptable/dose limiting toxicity (DLT) as defined any new Grade 2 or greater toxicity (based on CTCAE v 5).

Time frame: End of treatment (12 months)

Secondary Outcomes

Characterize the toxicities associated with the planned intervention

Incidence of unacceptable/dose limiting toxicity defined as any new ≥Grade 2 toxicity (based on CTCAE v 5) that cannot be attributed to the disease under treatment or other reason.

Time frame: 4 weeks after 1st dose of curcumin

To evaluate the effect of the intervention on BMI

The BMI will be measures across dose level group 95% confidence intervals.

Time frame: End of Treatment (12 months)

To evaluate the effect of the intervention on lipid panel

The lipid panel will be measures across dose level group 95% confidence intervals.

Time frame: End of Treatment (12 months)

To assess the effect of the intervention on quality of life

Focused on skin related morbidity and pain will be evaluated using the average and range of SkinDex scale (0-100)

Time frame: End of treatment (12 months)

To determine preliminary efficacy of the intervention

Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)

Time frame: End of treatment (12 months)

Data from ClinicalTrials.gov

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