Myelofibrosis Clinical Trial
— NUTRIENTOfficial title:
The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase
Verified date | March 2020 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 14-point Mediterranean Diet Adherence Screener (MEDAS) | 14 question survey assessing adherence to a Mediterranean diet. This is a 14 question survey, with possible 1 point per question. A perfect adherence to a Mediterranean Diet is 14 on this survey (min 0 max 14). Higher values represent closer adherence to a Mediterranean diet. | 15 weeks | |
Secondary | Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) | MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score, a validated measure for quantifying symptom burden in MPN. This is a 10 item survey, with each question answered on a scale of 0 to 10. The minimum score is 0, the maximum score is 100. Higher numbers mean a higher symptom burden. | 15 weeks | |
Secondary | Inflammatory cytokines | Measurement of inflammatory cytokines in the plasma. This includes EGF, Eotaxin, FGF-basic, G-CSF, GM-CSF, HGF, IFN-alpha, IFN-gamma, IL-1 beta, IL-1 alpha, IL-1RA, IL-2, IL-2R, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40/p70) IL-13, IL-15, IL-17A, IL-17F, IL-22, IP-10, MCP-1, MIG, MIP-1 alpha, MIP-1 beta, RANTES, TNF-alpha, VEGF. | 15 weeks |
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