Status:
ACTIVE_NOT_RECRUITING
NF-1, Nutraceutical Intervention
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Neurofibromatosis 1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05363267
Start Date
July 6 2022
End Date
August 1 2026
Last Update
September 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455