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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

Tracking Information
First Submitted Date  ICMJE April 5, 2010
First Posted Date  ICMJE April 8, 2010
Results First Submitted Date  ICMJE December 28, 2015
Results First Posted Date  ICMJE May 19, 2016
Last Update Posted Date May 19, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
To describe changes in neutrophil counts and neutrophil function in MDS patients following administration of Maitake mushroom extract. [ Time Frame: weeks 1, 3, 7, 9 and 12. ]
Change History Complete list of historical versions of study NCT01099917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
  • To evaluate the safety of Maitake in MDS patients. [ Time Frame: weeks 1, 3, 7, 9 and 12. ]
    Measured by serial Complete Chemistry Panels and Complete Review of Systems
  • To document any changes in hemoglobin level. [ Time Frame: weeks 1, 3, 7, 9 and 12 ]
  • To document any changes in platelet count [ Time Frame: weeks 1, 3, 7, 9 and 12. ]
  • To document any changes in reticulocyte count. [ Time Frame: weeks 1, 3, 7, 9 and 12 ]
  • To document any changes in monocyte function [ Time Frame: weeks 1, 3, 7, 9 and 12 ]
  • To document any changes in GM-CSF level. [ Time Frame: weeks 1, 3, 7, 9 and 12 ]
  • To document any changes in G-CSF level. [ Time Frame: weeks 1, 3, 7, 9 and 12 ]
  • To document any changes in Iron Studies. [ Time Frame: weeks 7 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
Official Title  ICMJE Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndrome
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Maitake
This is a phase II trial examining hematopoietic response in MDS patients.
Intervention: Drug: Maitake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2016)
45
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2010)
30
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01099917
Other Study ID Numbers  ICMJE 09-094
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • YUKIGUNI COMPANY
  • Weill Medical College of Cornell University
Investigators  ICMJE
Principal Investigator: Kathleen Wesa, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP