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Clinical Trials/NCT04744974
NCT04744974
Completed
Phase 2

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

University of California, Irvine1 site in 1 country28 target enrollmentJanuary 21, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Myeloproliferative Neoplasm
Sponsor
University of California, Irvine
Enrollment
28
Locations
1
Primary Endpoint
MPN Symptom Assessment form (MPN-SAF)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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. The 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. There has been a recently completed 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. This is a feasibility study to determine.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
December 6, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela G. Fleischman

Associate Professor, Division of Hematology/Oncology, Medicine

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

MPN Symptom Assessment form (MPN-SAF)

Time Frame: 16 weeks

validated survey tool to assess symptom burden in MPN

Study Sites (1)

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