Maitake for Integrative Cancer Care

NCT06323473 | Recruiting Phase 2

• 1 other identifier: Maitake001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Keywords

Chemotherapy; Maitake; Integrative Care; Integrative Medicine; Targeted Therapy; Neutrophil

Outcome Measures

Primary Outcomes (1)

• Changes in absolute neutrophil count

  The investigators will assess within-person changes in blood neutrophils throughout the study. Normal limit is 2.00 - 7.50 x 10\^9/L, where a higher neutrophil count will be considered an improvement. Values above the normal limit will be excluded due to the potential of infection.

  Baseline, week 4, week 8, week 12, week 16

Secondary Outcomes (9)

• Incidence of febrile neutropenia

  Baseline, week 4, week 8, week 12, week 16

• Change in neutrophil to lymphocyte ratio (NLR)

  Baseline, week 4, week 8, week 12, week 16

• Change in platelet to lymphocyte ratio (PLR)

  Baseline, week 4, week 8, week 12, week 16

• Change in high-sensitivity C-reactive protein (CRP)

  Baseline, week 4, week 8, week 12, week 16

• Changes in Quality of Life

  Baseline, week 4, week 8, week 12, week 16

Study Arms (1)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Black Maitake Prothera

Interventions

Black Maitake Prothera DIETARY_SUPPLEMENT

Mushroom extract; liquid

Also known as: Grifola Fondosa, Maitake

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years of age)
• Confirmed cancer diagnosis through biopsy or radiologic imaging
• Undergoing systemic treatment with either chemotherapy or CD4/6 inhibitors
• Currently receiving cancer treatment in Ontario, Canada

You may not qualify if:

• Hematologic cancers
• Previously received any mushroom supplement within 6 months prior to enrolment
• Allergy to mushrooms or mushroom products
• Diagnosis of diabetes
• Currently taking hypoglycemic or anticoagulant medications
• Currently receiving immune checkpoint inhibitors
• Unable to attend in in-person visits in either Ottawa or Toronto
• Any reason which, under the discretion of the Qualified Investigator or delegate, would preclude the patient from participating

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead

Study Sites (2)

The Centre for Health Innovation

Ottawa, Ontario, K2P 0M7, Canada

RECRUITING

Canadian College of Naturopathic Medicine - Integrative Cancer Centre

Toronto, Ontario, M2K 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Adrienne Junek, MD

  Centre for Health Innovation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Legacy

CONTACT

613-792-1222; mlegacy@thechi.ca

Dugald Seely

CONTACT

613-792-1222; dseely@thechi.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncontrolled single arm clinical trial

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 21, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CA (2)