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Trial Title:
Maitake for Integrative Cancer Care
NCT ID:
NCT06323473
Condition:
Cancer
Conditions: Keywords:
Chemotherapy
Maitake
Integrative Care
Integrative Medicine
Targeted Therapy
Neutrophil
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Uncontrolled single arm clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Black Maitake Prothera
Description:
Mushroom extract; liquid
Arm group label:
Treatment
Other name:
Grifola Fondosa
Other name:
Maitake
Summary:
Maitake is an edible mushroom that is used for both its nutritional and medicinal
properties. Human and animal studies have shown Maitake may help improve immune function;
however, its effectiveness in people with cancer is not clear. The investigators aim to
measure if Maitake has any immunomodulatory effects when given alongside conventional
systemic cancer therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adults (≥18 years of age)
2. Confirmed cancer diagnosis through biopsy or radiologic imaging
3. Undergoing systemic treatment with either chemotherapy or CD4/6 inhibitors
4. Currently receiving cancer treatment in Ontario, Canada
Exclusion Criteria:
1. Hematologic cancers
2. Previously received any mushroom supplement within 6 months prior to enrolment
3. Allergy to mushrooms or mushroom products
4. Diagnosis of diabetes
5. Currently taking hypoglycemic or anticoagulant medications
6. Currently receiving immune checkpoint inhibitors
7. Unable to attend in in-person visits in either Ottawa or Toronto
8. Any reason which, under the discretion of the Qualified Investigator or delegate,
would preclude the patient from participating
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Centre for Health Innovation
Address:
City:
Ottawa
Zip:
K2P 0M7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Mark Legacy
Phone:
613-792-1222
Phone ext:
1
Email:
mlegacy@thechi.ca
Facility:
Name:
Canadian College of Naturopathic Medicine - Integrative Cancer Centre
Address:
City:
Toronto
Zip:
M2K 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Daniel Lander
Phone:
416-498-1255
Phone ext:
280
Email:
dlander@ccnm.edu
Start date:
October 15, 2024
Completion date:
December 15, 2025
Lead sponsor:
Agency:
The Canadian College of Naturopathic Medicine
Agency class:
Other
Source:
The Canadian College of Naturopathic Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323473
