Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT04744974

Collaborator

(none)

Enrollment

Location

Arms

10.5

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloproliferative Neoplasm	Behavioral: Diet intervention	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 21, 2021

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mediterranean diet Participants will be given dietician counseling on a Mediterranean diet	Behavioral: Diet intervention Participants will be given dietician counseling on their assigned diet
Experimental: DASH diet Participants will be given dietician counseling on a DASH diet	Behavioral: Diet intervention Participants will be given dietician counseling on their assigned diet

Arm

Intervention/Treatment

Experimental: Mediterranean diet

Participants will be given dietician counseling on a Mediterranean diet

Behavioral: Diet intervention

Participants will be given dietician counseling on their assigned diet

Experimental: DASH diet

Participants will be given dietician counseling on a DASH diet

Behavioral: Diet intervention

Participants will be given dietician counseling on their assigned diet

Outcome Measures

Primary Outcome Measures

MPN Symptom Assessment form (MPN-SAF) [16 weeks]
validated survey tool to assess symptom burden in MPN

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92617

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator: Angela G. Fleischman, MD PhD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Angela G. Fleischman, Associate Professor, Division of Hematology/Oncology, Medicine, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT04744974

Other Study ID Numbers:

2020-5932
20-49

First Posted:

Feb 9, 2021

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Myeloproliferative Disorders

Study Results

No Results Posted as of Jun 22, 2022