Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

Phase 2

Completed

• Conditions: Myeloproliferative Neoplasm
• Interventions: Behavioral: Diet intervention

• Registration Number: NCT04744974
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	Diet intervention	Participants will be given dietician counseling on a Mediterranean diet
DASH diet	Diet intervention	Participants will be given dietician counseling on a DASH diet

Primary Outcome Measures

Name	Time	Method
MPN Symptom Assessment form (MPN-SAF)	16 weeks	validated survey tool to assess symptom burden in MPN

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States