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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelodysplastic Syndrome
Intervention Drug: Maitake
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maitake
Hide Arm/Group Description This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
Period Title: Overall Study
Started 45
Completed 18
Not Completed 27
Reason Not Completed
Adverse Event             3
Not Treated             24
Arm/Group Title Maitake
Hide Arm/Group Description This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  28.6%
>=65 years
15
  71.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
8
  38.1%
Male
13
  61.9%
1.Primary Outcome
Title Changes in Neutrophil Counts
Hide Description 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
Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maitake
Hide Arm/Group Description:
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
-0.3
(-0.5 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maitake
Hide Arm/Group Description This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
All-Cause Mortality
Maitake
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maitake
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
Blood and lymphatic system disorders   
Leukocytosis  1  1/21 (4.76%)  1
Platelet count decreased  1  1/21 (4.76%)  1
Eye disorders   
Eye disorders - Other  1  1/21 (4.76%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/21 (4.76%)  1
Gastrointestinal disorders - Other  1  1/21 (4.76%)  1
General disorders   
Aphonia  1  1/21 (4.76%)  1
Infections and infestations   
Lung infection  1  1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness right-sided  1  1/21 (4.76%)  1
Nervous system disorders   
Confusion  1  1/21 (4.76%)  1
Edema cerebral  1  1/21 (4.76%)  1
Stroke  1  1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/21 (4.76%)  1
Wheezing  1  1/21 (4.76%)  1
Skin and subcutaneous tissue disorders   
Pruritus  1  1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maitake
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Blood and lymphatic system disorders   
Blood bilirubin increased  1  2/21 (9.52%) 
Lymphocyte count decreased  1  2/21 (9.52%)  2
Neutrophil count decreased  1  10/21 (47.62%) 
Platelet count decreased  1  9/21 (42.86%)  9
White blood cell decreased  1  11/21 (52.38%) 
General disorders   
Headache  1  4/21 (19.05%) 
Pain in extremity  1  2/21 (9.52%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  4/21 (19.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Barrie Cassileth
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-0801
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01099917     History of Changes
Other Study ID Numbers: 09-094
First Submitted: April 5, 2010
First Posted: April 8, 2010
Results First Submitted: December 28, 2015
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016