The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myeloproliferative Disorder
- Sponsor
- University of California, Irvine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 14-point Mediterranean Diet Adherence Screener (MEDAS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Angela G. Fleischman
Assistant Professor, Division of Hematology/Oncology
University of California, Irvine
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
- Not provided
Outcomes
Primary Outcomes
14-point Mediterranean Diet Adherence Screener (MEDAS)
Time Frame: 15 weeks
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.
Secondary Outcomes
- Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)(15 weeks)
- Inflammatory cytokines(15 weeks)