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Trial record 2 of 7 for:    Myeloproliferative | cytokine

Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744974
Recruitment Status : Completed
First Posted : February 9, 2021
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Angela G. Fleischman, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE February 4, 2021
First Posted Date  ICMJE February 9, 2021
Last Update Posted Date June 22, 2022
Actual Study Start Date  ICMJE January 21, 2021
Actual Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
MPN Symptom Assessment form (MPN-SAF) [ Time Frame: 16 weeks ]
validated survey tool to assess symptom burden in MPN
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to either Mediterranean or Dietary Approaches to Stop Hypertension (DASH) diet
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Myeloproliferative Neoplasm
Intervention  ICMJE Behavioral: Diet intervention
Participants will be given dietician counseling on their assigned diet
Study Arms  ICMJE
  • Experimental: Mediterranean diet
    Participants will be given dietician counseling on a Mediterranean diet
    Intervention: Behavioral: Diet intervention
  • Experimental: DASH diet
    Participants will be given dietician counseling on a DASH diet
    Intervention: Behavioral: Diet intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2022)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
24
Actual Study Completion Date  ICMJE December 6, 2021
Actual Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04744974
Other Study ID Numbers  ICMJE 2020-5932
20-49 ( Other Identifier: Chao Family Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Angela G. Fleischman, University of California, Irvine
Original Responsible Party Angela G. Fleischman, University of California, Irvine, Faculty
Current Study Sponsor  ICMJE University of California, Irvine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angela G. Fleischman, MD PhD University of California, Irvine
PRS Account University of California, Irvine
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP