Myeloproliferative NeoplasmPhase 2NCT04744974
Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm
A Phase 2 study testing Diet intervention in people with Myeloproliferative Neoplasm, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 6 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92617
About this study
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
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.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Diet intervention
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionBehavioural
Participants will be given dietician counseling on their assigned diet
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Experimental | Participants will be given dietician counseling on a Mediterranean diet Receives: Behavioral: Diet intervention |
| DASH diet | Experimental | Participants will be given dietician counseling on a DASH diet Receives: Behavioral: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPN Symptom Assessment form (MPN-SAF)
validated survey tool to assess symptom burden in MPN
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start21 Jan 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either Mediterranean or Dietary Approaches to Stop Hypertension (DASH) diet
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela G. Fleischman, University of California, Irvine
- Investigators
- Angela G. Fleischman, MD PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744974
- Sponsor's protocol ID
- 2020-5932
- Other IDs
- 20-49
- Status last verified
- Jun 2022
- First submitted
- 4 Feb 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04744974
- Acronym / sponsor ID
- 2020-5932
- Conditions
- Myeloproliferative Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either Mediterranean or Dietary Approaches to Stop Hypertension (DASH) diet
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Experimental | Behavioral: Diet interventionParticipants will be given dietician counseling on a Mediterranean diet |
| DASH diet | Experimental | Behavioral: Diet interventionParticipants will be given dietician counseling on a DASH diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet interventionParticipants will be given dietician counseling on their assigned diet | Behavioural | DASH diet, Mediterranean diet |
Primary outcome
MPN Symptom Assessment form (MPN-SAF)
Time frame: 16 weeks
validated survey tool to assess symptom burden in MPN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Related trials for Myeloproliferative Neoplasm
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela G. Fleischman, MD PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diet intervention in people with Myeloproliferative Neoplasm, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPN Symptom Assessment form (MPN-SAF) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.