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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- MPN Symptom Assessment form (MPN-SAF)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Mediterranean diet
Participants will be given dietician counseling on a Mediterranean diet
Intervention: Diet intervention (Behavioral)
DASH diet
Participants will be given dietician counseling on a DASH diet
Intervention: Diet intervention (Behavioral)
Outcomes
Primary Outcomes
MPN Symptom Assessment form (MPN-SAF)
Time Frame: 16 weeks
validated survey tool to assess symptom burden in MPN
Secondary Outcomes
No secondary outcomes reported
Investigators
Angela G. Fleischman
Associate Professor, Division of Hematology/Oncology, Medicine
University of California, Irvine