NF-1, Nutraceutical Intervention

Neurofibromatosis 1 Clinical Trial

Official title:

Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363267
• Other study ID #: 2021LS032
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2022
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Fullenkamp Fullenkamp
• Phone: 612-625-6125
• Email: fulle631[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1

Intervention

Dietary Supplement:
• curcumin, high phenolic extra virgin olive oil (HP-EVOO)
identical for all participants with the exception of the curcumin dose level Dose 1: 1000 mg Curcumin daily dose with 1 capsule of 25 ml HP-EVOO volume at morning and night Dose 1: 2000 mg Curcumin daily dose with 2 capsules of 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules of 25 ml HP-EVOO volume at morning and night

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	End of treatment (12 months)
Secondary	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.	4 weeks after 1st dose of curcumin
Secondary	To evaluate the effect of the intervention on BMI	The BMI will be measures across dose level group 95% confidence intervals.	End of Treatment (12 months)
Secondary	To evaluate the effect of the intervention on lipid panel	The lipid panel will be measures across dose level group 95% confidence intervals.	End of Treatment (12 months)
Secondary	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)	End of treatment (12 months)
Secondary	To determine preliminary efficacy of the intervention	Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)	End of treatment (12 months)
Secondary	To identify issues with compliance to the planned intervention	Incidence of study deviations	End of treatment (12 months)