Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

Myeloproliferative Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744974
• Other study ID #: 2020-5932
• Secondary ID: 20-49
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: June 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms

Intervention

Behavioral:
• Diet intervention
Participants will be given dietician counseling on their assigned diet

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPN Symptom Assessment form (MPN-SAF)	validated survey tool to assess symptom burden in MPN	16 weeks