Skip to main content
OpenTrials
Completed

NCT Number: NCT04744974

Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Irvine

Irvine, California, 92617, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

diet intervention

Behavioral

Participants will be given dietician counseling on their assigned diet

Primary outcomes

  1. MPN Symptom Assessment form (MPN-SAF)

    Time frame: 16 weeks

    validated survey tool to assess symptom burden in MPN

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.