Cancer
Conditions
Keywords
Chemotherapy, Maitake, Integrative Care, Integrative Medicine, Targeted Therapy, Neutrophil
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.
Interventions
DIETARY_SUPPLEMENTBlack Maitake Prothera
Mushroom extract; liquid
Sponsors
The Canadian College of Naturopathic Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uncontrolled single arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in absolute neutrophil count | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia | 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. |
| Change in neutrophil to lymphocyte ratio (NLR) | 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. |
| Change in platelet to lymphocyte ratio (PLR) | 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. |
| Change in high-sensitivity C-reactive protein (CRP) | 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. |
| Changes in Quality of Life | 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. |
| Changes in hemoglobin A1c (HbA1c) | 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. |
| Incidence of adverse events | 16 weeks | The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0. |
| Incidence of dose reductions or delays in systemic therapy | 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. |
| Addition of new medications to combat neutropenia | 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. |
Countries
Canada
Contacts
CONTACTMark Legacy
CONTACTDugald Seely
PRINCIPAL_INVESTIGATORAdrienne Junek, MD
Centre for Health Innovation
Outcome results
None listed