Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e). Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.

Key facts

Study ID

NCT01099917

Run by

Memorial Sloan Kettering Cancer Center

People needed

45

Starts

2010-04-01

Expected to finish

2014-09-01

Last updated by the study team

2016-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• MSKCC patients age 18 or older able to sign informed consent
• Absolute Neutrophil count >0.5 K/mcL
• Diagnosis of MDS by bone marrow biopsy
• Patient not a candidate for aggressive standard treatment

You may not qualify if…

• IPSS (High risk)
• History of AML
• History of Stem Cell transplant
• Known history of HIV+
• Allergy to mushrooms
• Bone Marrow blasts >10%
• HEALTHY CONTROL ELIGIBILTY CRITERIA
• Inclusion Criteria
• Age ≥55 years
• Exclusion Criteria
• Currently taking corticosteroids or other immunosuppressants
• Known history of HIV+
• Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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