ACTIVE_NOT_RECRUITING

NF-1, Nutraceutical Intervention

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Conditions

Neurofibromatosis 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study of Nutraceutical Intervention With High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, Type 1 (NF1)

Quick Facts

Study Start:2022-07-06
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05363267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
  2. * Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
  3. * Aged 18 years or older at the time of written consent
  4. * Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care
  1. * Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
  2. * Conditions requiring systemic immunosuppression
  3. * Swallowing difficulties or strong gag reflex which may interfere with study compliance
  4. * Any comorbidities that may affect study participation in the judgement of enrolling investigator
  5. * Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
  6. * Treatment with high phenolic olive oil or curcumin within six months of study entry
  7. * Known pregnancy or anticipated conception during the 1 year study period

Contacts and Locations

Principal Investigator

Christopher Moertel, MD
PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, Univeristy of Minnesota

Study Locations (Sites)

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

  • Christopher Moertel, MD, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, Univeristy of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-06
Study Completion Date2026-08

Study Record Updates

Study Start Date2022-07-06
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Neurofibromatosis 1