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Trial record 2 of 7 for:    Myeloproliferative | cytokine

Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

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ClinicalTrials.gov Identifier: NCT04744974
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Angela G. Fleischman, University of California, Irvine

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. Our 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. We recently completed a 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. We are now moving on to a fully online dietary intervention to determine the impact of a Mediterranean diet on symptom burden among MPN patients. However, first we must establish that our fully online intervention and curriculum can be feasibly administered.

Here we describe our pilot study as a preparatory study designed to test the performance characteristics and capabilities of study designs, measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in our subsequent, larger study.


Condition or disease Intervention/treatment Phase
Myeloproliferative Neoplasm Behavioral: Diet intervention Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Official Title: 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
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mediterranean diet
Participants will be given dietician counseling on a Mediterranean diet
Behavioral: Diet intervention
Participants will be given dietician counseling on their assigned diet

Experimental: DASH diet
Participants will be given dietician counseling on a DASH diet
Behavioral: Diet intervention
Participants will be given dietician counseling on their assigned diet




Primary Outcome Measures :
  1. MPN Symptom Assessment form (MPN-SAF) [ Time Frame: 16 weeks ]
    validated survey tool to assess symptom burden in MPN



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744974


Contacts
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Contact: Angela G. Fleischman, MD PhD 949-999-2400 agf@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92617
Contact: Angela G Fleischman, MD PhD    949-999-2400    agf@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Angela G. Fleischman, MD PhD University of California, Irvine
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Responsible Party: Angela G. Fleischman, Faculty, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04744974    
Other Study ID Numbers: 2020-5932
20-49 ( Other Identifier: Chao Family Comprehensive Cancer Center )
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases