CancerPhase 2MaitakeNCT06323473
Maitake for Integrative Cancer Care
A Phase 2 study testing Black Maitake Prothera in people with Cancer, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Black Maitake Prothera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Oct 2024to 16 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Centre for Health Innovation
Ottawa, Ontario, K2P 0M7
Canadian College of Naturopathic Medicine - Integrative Cancer Centre
Toronto, Ontario, M2K 1E2
About this study
Official title: Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
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
- Being tested
- Black Maitake Prothera
- Keywords
- Chemotherapy, Maitake, Integrative Care, Integrative Medicine, Targeted Therapy, Neutrophil
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Maitake ProtheraDietary supplement
Also called Grifola Fondosa, Maitake
Mushroom extract; liquid
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors Receives: Dietary Supplement: Black Maitake Prothera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, week 8, week 12, week 16
Secondary outcomes (9)
Incidence of febrile neutropenia
Febrile neutropenia is defined as absolute neutrophil count < 1.0 x 10^9/L and temperature > 38.3 degrees Celsius.
Measured: Baseline, week 4, week 8, week 12, week 16
Change in neutrophil to lymphocyte ratio (NLR)
Higher NLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in NLR where a lower value in considered favourable. Values of neutrophils or lymphocytes outside the normal limit will be excluded due to the potential for infection.
Measured: Baseline, week 4, week 8, week 12, week 16
Change in platelet to lymphocyte ratio (PLR)
Higher PLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in PLR where a lower value in considered favourable. Values of lymphocytes outside the normal limit will be excluded due to the potential for infection.
Measured: Baseline, week 4, week 8, week 12, week 16
Change in high-sensitivity C-reactive protein (CRP)
CRP is a measure of inflammation. Higher levels of inflammation have been linked with poorer cancer prognosis. The investigators will assess within-person changes in CRP as a measure of systemic inflammation. Values less than 10 mg/mL are considered normal, with lower values being favourable.
Measured: Baseline, week 4, week 8, week 12, week 16
Changes in Quality of Life
QOL will be evaluated using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C30 (EORTC QLQ C30), version 3.0, a validated tool for analyzing health-related QOL in patients with cancer participating in clinical trials. The questionnaire incorporates five functional scales, (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a global health status, and a number of single items assessing additional symptoms. Scores range from 0-100 for each item. For functional scales and global health status, a higher score is favourable. For all symptom scales, a lower score is favourable.
Measured: Baseline, week 4, week 8, week 12, week 16
Changes in hemoglobin A1c (HbA1c)
HbA1c is a measure of blood glucose management, an item which is thought to be modulated by Maitake. The investigators will evaluate within-person changes in this metric as a measure of safety. Values below 5.7% are considered normal, with lower values being favourable.
Measured: Baseline, week 4, week 8, week 12, week 16
Incidence of adverse events
The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0.
Measured: 16 weeks
Incidence of dose reductions or delays in systemic therapy
The investigators will assess the frequency of dose delays or reductions in chemotherapy or CD4/6 inhibitors during the 16-week study period. Dose reductions or delays in treatment can negatively impact outcomes; not having reductions or delays is favourable.
Measured: 16 weeks.
Addition of new medications to combat neutropenia
The investigators will assess the incidence of participants requiring new medications (e.g., granulocyte colony-stimulating factor) prescribed to combat neutropenia throughout the 16-week study period. The addition of new medications can cause adverse effects and potentially delay other conventional treatments. The absence of additional medication is considered favourable.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Oct 2024
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled single arm clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne Junek, MD, Principal investigator, Centre for Health Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323473
- Sponsor's protocol ID
- Maitake001
- Acronym
- Maitake
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
- ClinicalTrials.gov ID
- NCT06323473
- Acronym / sponsor ID
- Maitake / Maitake001
- Conditions
- Cancer
- Keywords
- Chemotherapy, Maitake, Integrative Care, Integrative Medicine, Targeted Therapy, Neutrophil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled single arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Black Maitake ProtheraMaitake given alongside systemic chemotherapy and/or CD4/6 inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black Maitake ProtheraAlso: Grifola Fondosa, MaitakeMushroom extract; liquid | Dietary supplement | Treatment |
Primary outcome
Changes in absolute neutrophil count
Time frame: Baseline, week 4, week 8, week 12, week 16
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.
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Junek, MD principal investigator
Centre for Health Innovation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Black Maitake Prothera in people with Cancer, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in absolute neutrophil count (time frame: Baseline, week 4, week 8, week 12, week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.