What side effects are associated with this type of intervention?

Common treatments for Neurofibromatosis, particularly those with anti-inflammatory and antioxidant properties like Curcumin, include various nutraceuticals and supplements. Curcumin, often combined with high phenolic extra virgin olive oil (HP-EVOO), is generally well-tolerated with minimal side effects, which may include mild gastrointestinal discomfort. Other treatments may involve immunomodulators or chemotherapeutic agents, which can have more severe side effects such as neutropenia, peripheral neuropathy, and hypertension. It is important to consult with a healthcare provider to tailor the treatment plan to the individual's needs and monitor for any adverse effects.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Neurofibromatosis that focus on anti-inflammatory and antioxidant properties similar to curcumin. The context provided does not mention any such approvals. Treatments for Neurofibromatosis often involve managing symptoms and complications, with some investigational agents like selumetinib showing promise in clinical trials for NF1-associated low-grade gliomas.

What other types of research exist?

Promising novel alternatives to curcumin for Neurofibromatosis patients include high phenolic extra virgin olive oil (HP-EVOO), which has been used in combination with curcumin for its antioxidant properties. Additionally, exploring other nutraceuticals with strong anti-inflammatory and antioxidant effects, such as sulforaphane from broccoli sprouts, may offer potential benefits.

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Dietary Supplement

Nutraceuticals for Neurofibromatosis

Phase 1

Recruiting

Led By Christopher Moertel, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older at the time of written consent

NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing

Must not have

Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation

Conditions requiring systemic immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment (12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial involves taking curcumin and a special type of olive oil twice a day to help reduce inflammation and oxidative stress. It targets individuals who can tolerate this treatment for an extended period. Curcumin is a natural polyphenol known for its antioxidant and anti-inflammatory properties, and it has been studied in various contexts including metabolic syndrome, diabetes, and exercise-induced oxidative stress.

Who is the study for?

This trial is for adults over 18 with Neurofibromatosis (NF1) who have measurable skin neurofibromas. They must be able to give consent and not be on certain cancer drugs, immunosuppressants, or have swallowing issues that could affect taking the treatment. Pregnant individuals or those planning pregnancy during the study are excluded.

What is being tested?

The trial tests curcumin and high phenolic extra virgin olive oil (HP-EVOO) taken twice daily before meals for up to a year to see if they can help with NF1 symptoms. The only difference between participants is the dose of curcumin assigned when they join.

What are the potential side effects?

While specific side effects aren't listed, participants will stop treatment if they experience any unacceptable side effects related to the nutraceuticals being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with NF1 through genetic testing or NIH criteria.

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I have visible skin tumors due to neurofibromatosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently on treatments like selumetinib, MAPK, MEK, mTOR inhibitors, other targeted therapies, chemotherapy, or radiation.

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I am on medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Characterize the toxicities associated with the planned intervention

To assess the effect of the intervention on quality of life

To determine preliminary efficacy of the intervention

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Curcumin with high phenolic extra virgin olive oil (HP-EVOO)Experimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neurofibromatosis, particularly those similar to curcumin, often focus on anti-inflammatory and antioxidant mechanisms. Curcumin, for example, inhibits NF-κB activation, which reduces inflammation and tumor cell proliferation while promoting apoptosis. This is significant for NF patients as it can help manage tumor growth and associated symptoms. Other treatments, such as high phenolic extra virgin olive oil (HP-EVOO), also exhibit antioxidant properties that can mitigate oxidative stress, further contributing to the reduction of tumor progression and improving overall patient outcomes.

Pro-apoptotic genes as new targets for single and combinatorial treatments with resveratrol and curcumin in colorectal cancer.Curcumin ameliorates the in vitro efficacy of carfilzomib in human multiple myeloma U266 cells targeting p53 and NF-κB pathways.Recent progress on curcumin-based therapeutics: a patent review (2012-2016). Part I: Curcumin.