- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04744974
Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm
June 16, 2022 updated by: Angela G. Fleischman, University of California, Irvine
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92617
- University of California, Irvine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mediterranean diet
Participants will be given dietician counseling on a Mediterranean diet
|
Participants will be given dietician counseling on their assigned diet
|
EXPERIMENTAL: DASH diet
Participants will be given dietician counseling on a DASH diet
|
Participants will be given dietician counseling on their assigned diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MPN Symptom Assessment form (MPN-SAF)
Time Frame: 16 weeks
|
validated survey tool to assess symptom burden in MPN
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angela G. Fleischman, MD PhD, University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 21, 2021
Primary Completion (ACTUAL)
December 6, 2021
Study Completion (ACTUAL)
December 6, 2021
Study Registration Dates
First Submitted
February 4, 2021
First Submitted That Met QC Criteria
February 8, 2021
First Posted (ACTUAL)
February 9, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 16, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-5932
- 20-49 (OTHER: Chao Family Comprehensive Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myeloproliferative Neoplasm
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Sociedad de Lucha Contra el Cáncer del EcuadorCompletedMyeloproliferative Disorders | Myeloproliferative Neoplasm | Myeloproliferative Syndrome | Myeloproliferative Neoplasm, Unclassifiable | Myeloproliferative Disease, Not ClassifiedEcuador
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or AnemiaAnemia | Myelofibrosis | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedMyelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified | Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise SpecifiedUnited States
-
Astex Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative NeoplasmUnited States, Canada
-
ImmunoGen, Inc.Active, not recruitingBlastic Plasmacytoid Dendritic Cell Neoplasm | Myeloproliferative NeoplasmUnited States, Spain, Germany, Italy, France, United Kingdom
-
Fred Hutchinson Cancer CenterImmunoGen, Inc.RecruitingAcute Myeloid Leukemia | Myelodysplastic Syndrome | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative Neoplasm | Mixed Phenotype Acute LeukemiaUnited States
-
BeiGeneRecruitingAcute Myeloid Leukemia | Myelodysplastic Syndromes | Myelodysplastic/Myeloproliferative NeoplasmChina, United States, Australia, Spain, Korea, Republic of, New Zealand, Germany
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAcute Myeloid Leukemia | Myelodysplastic Syndrome | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
Fondazione per la Ricerca Ospedale MaggioreCompletedMyeloproliferative NeoplasmItaly, United Kingdom, Germany, France, United States, Spain, Canada
-
Safaa AA KhaledUnknownMyeloproliferative Neoplasm
Clinical Trials on Diet intervention
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University of Texas at AustinNational Cattlemen's Beef AssociationRecruitingEating Behavior | Breast Feeding, Exclusive | Glycemic ResponseUnited States
-
University of GuadalajaraCompletedObesity | Inflammatory Response | Exercise | Diet Habit | Abdominal ObesityMexico
-
Instituto Tecnológico y de Estudios Superiores...University of Guadalajara; Instituto Tecnológico de TepicCompletedDyslipidemias | Overweight and ObesityMexico
-
Azienda Ospedaliera Specializzata in Gastroenterologia...Antonella Bianco; Isabella FrancoRecruiting
-
University of ValenciaUnknownChildhood Obesity | Life Style | Circadian RhythmsSpain
-
Fazer GroupNokia Technologies Oy; Nightingale Health Oy; Tekes - the Finnish Funding Agency... and other collaboratorsCompletedCognitive Performance | Physiological Stress | LDL CholesterolFinland
-
University of AarhusUniversity of Copenhagen; University of Southern DenmarkRecruitingDiet; Deficiency | Exercise InterventionDenmark
-
Norwegian University of Science and TechnologySt. Olavs Hospital; FUGE Mid-NorwayCompletedCardiovascular Diseases | Obesity | Diabetes MellitusNorway
-
VA Office of Research and DevelopmentRecruitingPhysical Activity | Diet Quality | Peer LeadersUnited States
-
University of PecsRecruitingAcute PancreatitisHungary