Maitake for Integrative Cancer Care
ConditionCancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Canadian College of Naturopathic Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hematologic cancers
Previously received any mushroom supplement within 6 months prior to enrolment
Allergy to mushrooms or mushroom products
Diagnosis of diabetes
Trial design
Design model
Single group
Treatments tested in this trial
Black Maitake Prothera
Dietary supplementMushroom extract; liquid
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, week 4, week 8, week 12, week 16Secondary outcomes
1
Incidence of febrile neutropenia
Febrile neutropenia is defined as absolute neutrophil count \< 1.0 x 10\^9/L and temperature \> 38.3 degrees Celsius.
Time frame
Baseline, week 4, week 8, week 12, week 162
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.
Time frame
Baseline, week 4, week 8, week 12, week 163
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.
Time frame
Baseline, week 4, week 8, week 12, week 164
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.
Time frame
Baseline, week 4, week 8, week 12, week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov