Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

NCT04744974 | Completed Phase 2 DMC

• 2 other identifiers: 2020-593220-49
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

• MPN Symptom Assessment form (MPN-SAF)

  validated survey tool to assess symptom burden in MPN

  16 weeks

Study Arms (2)

Mediterranean diet

EXPERIMENTAL

Participants will be given dietician counseling on a Mediterranean diet

Behavioral: Diet intervention

DASH diet

EXPERIMENTAL

Participants will be given dietician counseling on a DASH diet

Behavioral: Diet intervention

Interventions

Diet intervention BEHAVIORAL

Participants will be given dietician counseling on their assigned diet

DASH diet; Mediterranean diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92617, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Angela G. Fleischman, MD PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Hematology/Oncology, Medicine

Model Details: Participants will be randomized to either Mediterranean or Dietary Approaches to Stop Hypertension (DASH) diet

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: January 21, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

US (1)