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Recruiting NCT06323473

Maitake for Integrative Cancer Care

Phase II Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Black Maitake Prothera.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy

Overview

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.

Interventions

  • Dietary supplement Black Maitake Prothera
    Mushroom extract; liquid

Primary outcome measures

  • Changes in absolute neutrophil count [Time frame: Baseline, week 4, week 8, week 12, week 16]
Secondary outcome measures (9)
  • Incidence of febrile neutropenia [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Change in neutrophil to lymphocyte ratio (NLR) [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Change in platelet to lymphocyte ratio (PLR) [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Change in high-sensitivity C-reactive protein (CRP) [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Changes in Quality of Life [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Changes in hemoglobin A1c (HbA1c) [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Incidence of adverse events [Time frame: 16 weeks]
  • Incidence of dose reductions or delays in systemic therapy [Time frame: 16 weeks.]
  • Addition of new medications to combat neutropenia [Time frame: 16 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • The Centre for Health Innovation — Ottawa
  • Canadian College of Naturopathic Medicine - Integrative Cancer Centre — Toronto

Identifiers

NCT: NCT06323473 · Maitake001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗