NF-1, Nutraceutical Intervention

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Apr 29, 2022

Keywords

ClinConnect Summary

This clinical trial, called the NF-1 Nutraceutical Intervention, is studying whether a combination of curcumin (a natural compound found in turmeric) and high-quality olive oil can help people with Neurofibromatosis 1 (NF1). NF1 is a genetic condition that can cause tumors to grow on nerves, and the trial aims to see how these supplements affect skin tumors called cutaneous neurofibromas. Participants in the study will take curcumin and olive oil twice a day on an empty stomach for up to 12 months, and the dose of curcumin will vary for each person based on what they are assigned when they join the trial.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of NF1. They should have measurable skin tumors and be willing to follow the study instructions, including taking the supplements regularly. However, individuals who are currently receiving certain medications or treatments, have swallowing difficulties, or are pregnant cannot participate. This trial is currently recruiting participants of all genders, and those who join can expect close monitoring for any side effects during their treatment. It's a great opportunity for those looking to explore new options in managing their NF1 condition.

Gender

ALL

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