Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Myelodysplastic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099917
• Other study ID #: 09-094
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2010
• Last updated: September 3, 2014
• Start date: April 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University, YUKIGUNI COMPANY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe changes in neutrophil counts and neutrophil function in MDS patients following administration of Maitake mushroom extract.		weeks 1, 3, 7, 9 and 12.	No
Secondary	To evaluate the safety of Maitake in MDS patients.	Measured by serial Complete Chemistry Panels and Complete Review of Systems	weeks 1, 3, 7, 9 and 12.	Yes
Secondary	To document any changes in hemoglobin level.		weeks 1, 3, 7, 9 and 12	No
Secondary	To document any changes in platelet count		weeks 1, 3, 7, 9 and 12.	No
Secondary	To document any changes in reticulocyte count.		weeks 1, 3, 7, 9 and 12	No
Secondary	To document any changes in monocyte function		weeks 1, 3, 7, 9 and 12	No
Secondary	To document any changes in GM-CSF level.		weeks 1, 3, 7, 9 and 12	No
Secondary	To document any changes in G-CSF level.		weeks 1, 3, 7, 9 and 12	No
Secondary	To document any changes in Iron Studies.		weeks 7 and 12	No

External Links

•   Memorial Sloan-Kettering Cancer Center