Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    24
  • sponsor
    University of California, Irvine
Updated on 18 February 2021

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.

Details
Condition MYELOPROLIFERATIVE DISORDER, Myeloproliferative Neoplasms, myeloproliferative neoplasm, myeloproliferative disorders
Treatment Diet intervention
Clinical Study IdentifierNCT04744974
SponsorUniversity of California, Irvine
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: myeloproliferative neoplasm or Myeloproliferative Neoplasms or myeloproliferative disorders or MYELOPROLIFERATIVE DISORDER?
Do you have any of these conditions: myeloproliferative disorders or Myeloproliferative Neoplasms or myeloproliferative neoplasm or MYELOPROLIFERATIVE DISORDER?
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)
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