Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

NCT ID: NCT04744974

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2021-12-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mediterranean diet

Participants will be given dietician counseling on a Mediterranean diet

Group Type: EXPERIMENTAL

Diet intervention

Intervention Type: BEHAVIORAL

Participants will be given dietician counseling on their assigned diet

DASH diet

Participants will be given dietician counseling on a DASH diet

Group Type: EXPERIMENTAL

Diet intervention

Intervention Type: BEHAVIORAL

Participants will be given dietician counseling on their assigned diet

Interventions

Diet intervention

Participants will be given dietician counseling on their assigned diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Angela G. Fleischman

Associate Professor, Division of Hematology/Oncology, Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela G. Fleischman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

20-49

Identifier Type: OTHER

Identifier Source: secondary_id

2020-5932

Identifier Type: -

Identifier Source: org_study_id