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Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

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ClinicalTrials.gov Identifier: NCT01099917
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborators:
YUKIGUNI COMPANY
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Maitake Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maitake
This is a phase II trial examining hematopoietic response in MDS patients.
Drug: Maitake

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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099917


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
YUKIGUNI COMPANY
Weill Medical College of Cornell University
Investigators
Principal Investigator: Kathleen Wesa, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01099917     History of Changes
Other Study ID Numbers: 09-094
First Posted: April 8, 2010    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016
Last Verified: April 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
MDS
Maitake
mushroom
09-094

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms