Phase 2 Completed N=45 Treatment

Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Myelodysplastic Syndromes

Source: ClinicalTrials.gov NCT01099917 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

May 2016

Primary outcomePrimary: Changes in Neutrophil Counts — -0.3 cells/mm^3

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Neutrophil Counts	-0.3	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01099917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.