Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maitake

Drug

Patients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol.

Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test.

Primary outcomes

Changes in Neutrophil Counts

Time frame: baseline and week 12

The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Weill Medical College of Cornell University
YUKIGUNI COMPANY

Registry information

Official study title

Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Apr 8, 2010
Registry last updated: May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed