Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN)
Condition: Myelodysplastic Syndromes
MeSH terms: Neoplasms; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Syndrome
Intervention: Freeze-Dried Black Raspberry Powder
Intervention description: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Black raspberries; MDS; Myelodysplastic Syndromes; hypomethylating effects; chemopreventive agent; BRB; pharmacokinetics

Summary:

      This is a phase II, single-group pilot study to evaluate efficacy and methylation. This
      study's overarching aim is to evaluate the systemic effects of black raspberries in patients
      with myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
      Twenty-one patients with MDS will be treated with 25 gm (2x/day) of BRB powder taken orally.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a confirmed diagnosis of myelodysplastic syndrome or
             myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) proven by bone marrow
             biopsy/aspirate.

          2. Patients with cytopenias (blood cell counts lower than the institutional lower limit
             of normal within the eight weeks prior to the study) who are receiving or received:

               -  red blood cell transfusions

               -  observation

               -  platelet transfusions

               -  erythropoietin

               -  granulocyte colony-stimulating factors

               -  granulocyte-macrophage colony-stimulating factors

               -  hydrea

          3. Age >18 years.

          4. Predicted life expectancy of at least 12 weeks.

          5. Patients should be expected to stay on the same therapy for the period of the study.

          6. Patients who do not have an indication for and/or are unable to tolerate a
             hypomethylating agent are eligible for the study.

          7. Reproductive requirements:

             Female patients must meet one of the following:

               -  Postmenopausal for at least one year before the screening visit, or

               -  Surgically sterile, or

               -  If women are of childbearing potential, agree to practice two effective methods
                  of contraception from the time of signing of the informed consent form through 30
                  days after the last dose of study drug, AND

               -  Must also adhere to the guidelines of any treatment-specific pregnancy prevention
                  program, if applicable, or

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, postovulation methods] and withdrawal are not acceptable
                  contraception methods.)

             Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree
             to one of the following:

               -  Practice effective barrier contraception during the entire study treatment period
                  and through 30 days after the last study drug dose, OR

               -  Must also adhere to the guidelines of any treatment-specific pregnancy prevention
                  program, if applicable, OR

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, postovulation methods] and withdrawal are not acceptable methods
                  of contraception.)

          8. Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

        A potential subject who meets any of the following exclusion criteria is ineligible to
        participate in the study.

          1. Previously received hypomethylating agents.

          2. Allergy to black raspberries.

          3. Inability to swallow oral medication.

          4. Inability or unwillingness to comply with the BRB administration requirements.

          5. Uncontrolled intercurrent illness, including, but not limited to, symptomatic
             congestive heart failure, or psychiatric illness/social situations, that, in the
             treating investigator's discretion, would limit compliance with study requirements.

          6. Active infection not well controlled by antibacterial or antiviral therapy.

          7. Pregnant or lactating women.

          8. Participation in clinical trials with other investigational agents not included in
             this trial, within 14 days of the start of this trial and throughout the duration of
             this trial.