Lifestyle Intervention for Myeloproliferative Disorder

Recruiting at 2 trial locations

Overseen By Gabriella Hobbs, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Intermediate-2/high-risk MF, ECOG >2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if individuals with myeloproliferative disorders (a group of blood diseases) can complete a 12-week program designed to enhance heart health through improved nutrition and increased physical activity. Participants will engage in a combination of virtual and in-person group classes, focusing on healthy lifestyle changes as part of the Cardiac Lifestyle Program. The trial seeks individuals diagnosed with specific myeloproliferative disorders who also have a cardiovascular risk factor, such as high blood pressure or diabetes.

As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to improved heart health strategies for those with blood disorders.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cardiac Lifestyle Program is safe for patients with myeloproliferative disorders?

Studies have shown that lifestyle changes, such as eating better and being more active, are generally safe. The Cardiac Lifestyle Program emphasizes these changes. Research indicates that these programs do not involve medication or medical procedures, reducing the risk of unwanted effects.

People who have made similar lifestyle changes often report feeling healthier overall. These programs can improve heart health, which is crucial because individuals with myeloproliferative disorders face a higher risk of heart problems. No specific reports of serious side effects have emerged from programs like this.

Overall, the Cardiac Lifestyle Program is well-tolerated and considered safe for most people. This program aims to help participants become more active and eat healthier, enhancing their general well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cardiac Lifestyle Program is unique because it combines heart-healthy habits with structured group support to manage myeloproliferative disorders. Unlike traditional treatments like medications or chemotherapy, this program uses a mix of virtual and in-person classes to promote lifestyle changes that may improve cardiovascular health and overall well-being. Researchers are excited about this approach because it could offer a non-invasive, holistic method to manage these conditions, potentially reducing the need for more aggressive treatments.

What evidence suggests that the Cardiac Lifestyle Program is effective for myeloproliferative disorders?

Research has shown that lifestyle changes, like those in the Cardiac Lifestyle Program, can benefit people with myeloproliferative disorders (MPDs). Studies have found that patients with MPDs often face heart-related issues, and healthier living can help manage these risks. By eating better and being more active, patients might reduce their chances of heart problems. Although specific data on the Cardiac Lifestyle Program's effectiveness for MPDs is lacking, the idea is that improving heart health could enhance overall well-being for those with these blood disorders. Participants in this trial will engage in the Cardiac Lifestyle Program to explore its potential benefits for managing MPDs. ^{2 3 6 7 8}

Who Is on the Research Team?

Gabriela Hobbs, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with myeloproliferative disorders (like ET, PV, pre-MF, MF, or MPN-NOS) who are low to intermediate-1 risk. They should be fairly active (ECOG status 0-1) and have at least one cardiovascular risk factor such as being overweight or having high blood pressure, cholesterol issues, diabetes/pre-diabetes/metabolic syndrome, or a history of heart disease.

Inclusion Criteria

I have been diagnosed with a specific blood disorder according to WHO 2016 criteria.

I have a cardiovascular risk such as high BMI, high blood pressure, high cholesterol, diabetes, or a history of heart disease.

I am fully active or can carry out light work.

Exclusion Criteria

Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.

My myelofibrosis is classified as intermediate-2 or high-risk.

I need assistance with my daily activities due to my health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in a 12-week Cardiac Lifestyle Program involving exercise and nutrition

12 weeks

6 virtual group classes, 6 in-person group classes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Lifestyle Program

Trial Overview The study tests the Cardiac Lifestyle Program (CLP), which lasts for 12 weeks and focuses on helping patients become more physically active and eat healthier. The program is tailored to each individual's needs.

How Is the Trial Designed?

Group I: Cardiac Lifestyle Program Experimental Treatment 1 Intervention

Participants will complete study procedures as follows: * Baseline in-clinic visit with research team doctor for history and physical and the completion of questionnaires. * 6 virtual group classes alternating with 6 in-person group classes. * Semi-structured exit interview.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11523155/

Long-term risks of cardiovascular-specific mortality among ... Among these patients, 8841 experienced death during the follow-up period after diagnosis, of which 2664 (30.1%) died from MPN, 2429 (27.5%) died from CVD, 777 ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39781540/

Trends and disparities in cardiovascular disease-related ... Conclusion: Our findings indicate a significant decline with notable gender, racial/ethnic, and regional differences in CVD-related mortality ...

3. ashpublications.org ashpublications.org/ashclinicalnews/news/6428/Cardiovascular-Disease-and-Myeloproliferative

Cardiovascular Disease and Myeloproliferative Neoplasms “Our cancer treatments are getting better and better every year, patients are living so much longer, even patients with MPNs have life ...

4. hematologyadvisor.com hematologyadvisor.com/features/myeloproliferative-neoplasms-treatment-outcomes/

Myeloproliferative Neoplasms Treatment: New Insights The results demonstrated a median overall survival (OS) of 0.86 years, with no significant differences observed by first-line treatment type.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124094874

Myocardial Ischemia in Patients Living with ... Patients with MPNs that developed MI have both major bleeding and thrombotic complications even while being on guideline-directed therapy.

6. medsearchglobal.com medsearchglobal.com/antistudydetail/NCT05842603

Myeloproliferative Disorders - NCT05842603 Brief Summary: The goal of this study is to see if patients with myeloproliferative disorders are able to successfully complete the Cardiac Lifestyle ...

7. finance.yahoo.com finance.yahoo.com/news/prelude-therapeutics-announces-publication-abstracts-140100649.html

Prelude Therapeutics Announces Publication of Abstracts ... These compounds demonstrate mutant specific inhibition in multiple preclinical models of myeloproliferative neoplasms (MPNs). In our mCALR DAC ...

8. mdpi.com mdpi.com/2077-0383/14/14/5080

Management of Myeloproliferative Neoplasms While data on pharmacokinetics and safety are available, as well as new high-availability formulations, the possible interaction with anticoagulant or anti ...