NCT03140280

Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN)

A Pilot Study to Investigate the Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ehab L Atallah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

STUDY RATIONALE: Hypomethylating agents (HMAs) such as azacitidine and decitabine are FDA approved therapies for MDS patients. Approximately 50% of patients respond to HMAs. In addition, HMAs have improved survival and quality of life of patients with MDS when compared with other therapies. Preclinical research shows black raspberries (BRBs) have hypomethylating effects in the colon, blood, spleen, and bone marrow of mice treated with BRBs. The aim of this study is to evaluate the hypomethylating properties of BRBs in patients with MDS or MDS/MPN for three cycles (one cycle = 28 days) of BRB supplementation. PRIMARY OBJECTIVE: To evaluate the potential hypomethylating effects of freeze-dried black raspberries (BRBs) in the peripheral blood of patients with myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) after three cycles of BRB administration. SECONDARY OBJECTIVE: 1. To evaluate the toxicity of BRBs in patients with MDS or MDS/MPN. 2. To evaluate the hematological response according to modified International Working Group (IWG) criteria (Appendix 2) in patients with MDS or MDS/MPN regardless of the initial blood count.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Freeze-Dried Black Raspberry Powder	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.

Timeline

• Start date: 2017-06-05
• Primary completion: 2019-06-01
• Completion: 2021-05-28
• First posted: 2017-05-04
• Last updated: 2022-11-04
• Results posted: 2022-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study