Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Changes in absolute neutrophil count
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors
Intervention: Black Maitake Prothera (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Incidence of febrile neutropenia(Baseline, week 4, week 8, week 12, week 16)
- Change in neutrophil to lymphocyte ratio (NLR)(Baseline, week 4, week 8, week 12, week 16)
- Change in platelet to lymphocyte ratio (PLR)(Baseline, week 4, week 8, week 12, week 16)
- Changes in Quality of Life(Baseline, week 4, week 8, week 12, week 16)
- Changes in hemoglobin A1c (HbA1c)(Baseline, week 4, week 8, week 12, week 16)
- Incidence of adverse events(16 weeks)
- Incidence of dose reductions or delays in systemic therapy(16 weeks.)
- Addition of new medications to combat neutropenia(16 weeks)
- Change in high-sensitivity C-reactive protein (CRP)(Baseline, week 4, week 8, week 12, week 16)