Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California
Dates
study started
estimated completion
Principal Investigator
by Angela G. Fleischman, MD PhD

Description

Summary

Myeloproliferative Neoplasm (MPN) is a chronic blood cancer without cure. The major clinical issues in MPN are 1) an increased risk of blood clots 2) symptoms thought to be driven by chronic inflammation which in some cases can be debilitating and 3) progression to acute leukemia. Our current management of MPN focuses on preventing blood clots and relieving symptoms. However, treatments that reduce symptoms such as JAK inhibitors are limited to late stage MPN patients and have significant side effects including immunosuppression, reduction in platelets, and increased risk of skin cancer. Therefore, low risk interventions are sorely needed for MPN patients that can reduce symptoms. Diet represents a low risk way to reduce inflammation, specifically a Mediterranean diet has been found to reduce inflammation in cardiovascular disease. We recently completed a clinical trial that demonstrated MPN patients can adopt a Mediterranean diet if given dietician counseling and curriculum. However, in order to reach a larger group of people a fully remotely administered study is necessary. We are now moving on to a fully online dietary intervention to determine the impact of a Mediterranean diet on symptom burden among MPN patients. However, first we must establish that our fully online intervention and curriculum can be feasibly administered. Here we describe our pilot study as a preparatory study designed to test the performance characteristics and capabilities of study designs, measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in our subsequent, larger study.

Official Title

A Randomized Clinical Trial to Assess the Impact of a Remotely Administered Diet Intervention on Symptom Burden and Inflammatory Cytokines in Myeloproliferative Neoplasm: Feasibility Phase

Keywords

Myeloproliferative Neoplasm Neoplasms Myeloproliferative Disorders Diet intervention Mediterranean diet DASH diet

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥18 with a diagnosis of a Philadelphia chromosome negative Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF)
  • Has access to the internet and email
  • MPN-Total Symptom Score (MPN-TSS) score of ≥10 on screening survey
  • Mediterranean Adherence score of ≤10 on screening survey
  • English fluency (intervention requires conversations with study staff)
  • In the opinion of the study team is amenable to changing one's diet

You CAN'T join if...

  • Pregnant or planning to become pregnant over the course of the study
  • Has food allergies, intolerances, or other dietary restrictions which would severely limit changes to their diet toward a Mediterranean style diet (such as allergies to ALL tree nuts or olive oil)

Location

  • University of California, Irvine accepting new patients
    Irvine California 92617 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04744974
Phase
Phase 2
Study Type
Interventional
Last Updated