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NCT Number: NCT06323473

Maitake for Integrative Cancer Care

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Centre for Health Innovation, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black Maitake Prothera

Dietary Supplement

Mushroom extract; liquid

Other names: Grifola Fondosa, Maitake

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of febrile neutropenia

    Time frame: Baseline, week 4, week 8, week 12, week 16

    Febrile neutropenia is defined as absolute neutrophil count < 1.0 x 10^9/L and temperature > 38.3 degrees Celsius.

  2. Change in neutrophil to lymphocyte ratio (NLR)

    Time frame: Baseline, week 4, week 8, week 12, week 16

    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.

  3. Change in platelet to lymphocyte ratio (PLR)

    Time frame: Baseline, week 4, week 8, week 12, week 16

    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.

  4. Change in high-sensitivity C-reactive protein (CRP)

    Time frame: Baseline, week 4, week 8, week 12, week 16

    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.

  5. Changes in Quality of Life

    Time frame: Baseline, week 4, week 8, week 12, week 16

    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.

  6. Changes in hemoglobin A1c (HbA1c)

    Time frame: Baseline, week 4, week 8, week 12, week 16

    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.

  7. Incidence of adverse events

    Time frame: 16 weeks

    The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0.

  8. Incidence of dose reductions or delays in systemic therapy

    Time frame: 16 weeks.

    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.

  9. Addition of new medications to combat neutropenia

    Time frame: 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dugald Seely

CONTACT

[email protected]

613-792-1222 ext. 1

Mark Legacy

CONTACT

[email protected]

613-792-1222 ext. 1

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Registry information

Official study title

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

Acronym: Maitake

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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