Clinical trial · Interventional
Maitake for Integrative Cancer Care
Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
NCT06323473CI-TRIAL-00101506MaitakerecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Black Maitake Prothera | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors
- interventionNames
- Dietary Supplement: Black Maitake Prothera
Primary outcomes (1)
- measure
- Changes in absolute neutrophil count
- timeFrame
- Baseline, week 4, week 8, week 12, week 16
- description
- 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 (9)
- measure
- Incidence of febrile neutropenia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.