Recruiting
Phase 2

Maitake

Sponsor:

The Canadian College of Naturopathic Medicine

Code:

NCT06323473

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Black Maitake Prothera

Study Details

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

Study ID

NCT06323473

Start date

Oct 15, 2024

Status verified date

Jan, 2026

Completion date

May 15, 2026

Anticipated

Primary completion date

May 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

Black Maitake Prothera

Mushroom extract; liquid

Primary outcome measure

  • Changes in absolute neutrophil count [ Time Frame: Baseline, week 4, week 8, week 12, week 16 ]

Central Contacts and Locations

Central contacts

Mark Legacy

613-792-1222mlegacy@thechi.ca

Dugald Seely

613-792-1222dseely@thechi.ca

Locations

The Centre for Health Innovation

Recruiting

Ottawa, Ontario, Canada, K2P 0M7

Contacts

Mark Legacy

613-792-1222mlegacy@thechi.ca

Canadian College of Naturopathic Medicine - Integrative Cancer Centre

Recruiting

Toronto, Ontario, Canada, M2K 1E2

Contacts

Daniel Lander

416-498-1255dlander@ccnm.edu

More Information

Sponsor

The Canadian College of Naturopathic Medicine

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Canadian College of Naturopathic Medicine on 2026-01-23.