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NF-1, Nutraceutical Intervention

Primary Purpose

Neurofibromatosis 1

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofibromatosis 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Masonic Cancer Center, University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
To evaluate the effect of the intervention on BMI
The BMI will be measures across dose level group 95% confidence intervals.
To evaluate the effect of the intervention on lipid panel
The lipid panel will be measures across dose level group 95% confidence intervals.
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)
To determine preliminary efficacy of the intervention
Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)
To identify issues with compliance to the planned intervention
Incidence of study deviations

Full Information

First Posted
April 26, 2022
Last Updated
August 25, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05363267
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Curcumin with high phenolic extra virgin olive oil (HP-EVOO)
Arm Type
Experimental
Arm Description
Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.
Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Other Intervention Name(s)
curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Characterize the toxicities associated with the planned intervention
Description
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
Title
To evaluate the effect of the intervention on BMI
Description
The BMI will be measures across dose level group 95% confidence intervals.
Time Frame
End of Treatment (12 months)
Title
To evaluate the effect of the intervention on lipid panel
Description
The lipid panel will be measures across dose level group 95% confidence intervals.
Time Frame
End of Treatment (12 months)
Title
To assess the effect of the intervention on quality of life
Description
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)
Title
To determine preliminary efficacy of the intervention
Description
Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported)
Time Frame
End of treatment (12 months)
Title
To identify issues with compliance to the planned intervention
Description
Incidence of study deviations
Time Frame
End of treatment (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fullenkamp Fullenkamp
Phone
612-625-6125
Email
fulle631@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kris Beatrez
Phone
612-624-1928
Email
kbeatrez@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Moertel, MD
Organizational Affiliation
Masonic Cancer Center, Univeristy of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Moertel, M.D.
Phone
612-626-2778
Email
moert001@umn.edu
First Name & Middle Initial & Last Name & Degree
Christopher Moertel, M.D.

12. IPD Sharing Statement

Learn more about this trial

NF-1, Nutraceutical Intervention

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