Myeloproliferative Neoplasms Clinical Trial

The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase

Summary

The purpose of this study is to determine whether MPN patient are able to adhere to a dietary intervention. Participants will be randomized to one of two healthy diets. Participants will receive in person dietician counseling and online curriculum. Adherence will be measured using online surveys and phone diet recalls. Changes in inflammatory markers in blood will also be measured at 5 time points during this 15 week study.

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Full Description

This is a 15 week study, including 10 weeks of active diet intervention. Each participant will receive one dietician counseling session at the beginning of the diet intervention period, two brief follow up dietician phone calls, and 10 diet education handouts delivered via email each week. The main objective of this protocol is to test whether MPN patients can adhere to a diet intervention. The investigators will measure adherence in both arms with patient reported diet recall every two weeks via internet surveys. As exploratory endpoints the investigators will measure changes in inflammatory markers, symptom burden, physical activity level, sleep, and gut microbiome in participants over the course of the study. If successful, the investigators plan to use this intervention in a larger trial to assess whether a diet intervention can effectively change symptom burden and inflammation in MPN patients.

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Eligibility Criteria

Inclusion Criteria:

At least 18 years old
Diagnosis of Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF)
Any type of previous therapy is allowed
ECOG performance status ≤2
Life expectancy of greater than 20 weeks
Has an email address and can access the internet
Able to read and understand English

Exclusion Criteria:

Children

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

30

Study ID:

NCT03907436

Recruitment Status:

Completed

Sponsor:

University of California, Irvine

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There is 1 Location for this study

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University of California, Irvine
Irvine California, 92617, United States

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Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

30

Study ID:

NCT03907436

Recruitment Status:

Completed

Sponsor:


University of California, Irvine

How clear is this clinincal trial information?

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