Neurofibromatosis 1Phase 1NCT05363267
NF-1, Nutraceutical Intervention
A Phase 1 study testing curcumin, high phenolic extra virgin olive oil (HP-EVOO) in people with Neurofibromatosis 1, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis 1
- What is being tested?
- curcumin, high phenolic extra virgin olive oil (HP-EVOO)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
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.
- Conditions
- Neurofibromatosis 1
- Being tested
- curcumin, high phenolic extra virgin olive oil (HP-EVOO)
- Medical subject headings
- Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin, high phenolic extra virgin olive oil (HP-EVOO)Dietary supplement
Also called 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 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
| Study group | Role | What they receive |
|---|---|---|
| Curcumin with high phenolic extra virgin olive oil (HP-EVOO) | Experimental | Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment. Receives: Dietary Supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: End of treatment (12 months)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: End of treatment (12 months)
To identify issues with compliance to the planned intervention
Incidence of study deviations
Measured: End of treatment (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start6 Jul 2022
- Primary completion2 Sep 2025
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clay Hoerig, MD, Principal investigator, Masonic Cancer Center, Univeristy of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363267
- Sponsor's protocol ID
- 2021LS032
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)
- ClinicalTrials.gov ID
- NCT05363267
- Acronym / sponsor ID
- 2021LS032
- Conditions
- Neurofibromatosis 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin with high phenolic extra virgin olive oil (HP-EVOO) | Experimental | Dietary Supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO)Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumin, high phenolic extra virgin olive oil (HP-EVOO)Also: 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 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 | Dietary supplement | Curcumin with high phenolic extra virgin olive oil (HP-EVOO) |
Primary outcome
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.
Time frame: End of treatment (12 months)
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).
6 secondary outcomes
Characterize the toxicities associated with the planned intervention
Time frame: 4 weeks after 1st dose of curcumin
To evaluate the effect of the intervention on BMI
Time frame: End of Treatment (12 months)
To evaluate the effect of the intervention on lipid panel
Time frame: End of Treatment (12 months)
To assess the effect of the intervention on quality of life
Time frame: End of treatment (12 months)
To determine preliminary efficacy of the intervention
Time frame: End of treatment (12 months)
To identify issues with compliance to the planned intervention
Time frame: End of treatment (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for Neurofibromatosis 1
Active, not recruitingObservational study
Natural History Study of Cutaneous Neurofibromas in People With NF1
Neurofibromatosis Type 1, Neurofibromatosis 1
RecruitingObservational study
The NF Registry Sponsored by the Children's Tumor Foundation
Neurofibromatosis 1, Neurofibromatosis 2
RecruitingObservational study
Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
Neurofibromatosis Type 1 (NF1)
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Not yet recruitingPhase 1
A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clay Hoerig, MD principal investigator
Masonic Cancer Center, Univeristy of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing curcumin, high phenolic extra virgin olive oil (HP-EVOO) in people with Neurofibromatosis 1, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: End of treatment (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.