Maitake for Integrative Cancer Care

NCT ID: NCT06323473

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Uncontrolled single arm clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors

Group Type EXPERIMENTAL

Black Maitake Prothera

Intervention Type DIETARY_SUPPLEMENT

Mushroom extract; liquid

Interventions

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Black Maitake Prothera

Mushroom extract; liquid

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Grifola Fondosa Maitake

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrienne Junek, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Health Innovation

Locations

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The Centre for Health Innovation

Ottawa, Ontario, Canada

Site Status RECRUITING

Canadian College of Naturopathic Medicine - Integrative Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mark Legacy

Role: CONTACT

613-792-1222 ext. 1

Dugald Seely

Role: CONTACT

613-792-1222 ext. 1

Facility Contacts

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Mark Legacy

Role: primary

613-792-1222 ext. 1

Daniel Lander

Role: primary

416-498-1255 ext. 280

Other Identifiers

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Maitake001

Identifier Type: -

Identifier Source: org_study_id

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