Clinical trial NCT03907436: The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase
Official title: The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myeloproliferative Disorder
Myeloproliferative Syndrome
Myelofibrosis
Polycythemia Vera
Essential Thrombocythemia
Keywords: nutrition
diet
inflammation
myeloproliferative neoplasm
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two healthy diets (USDA or Mediterranean diet)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 14-point Mediterranean Diet Adherence Screener (MEDAS)
timeFrame: 15 weeks
Secondary outcomes:
measure: Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
timeFrame: 15 weeks
measure: Inflammatory cytokines
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Angela G Fleischman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: