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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Maitake Prothera | Dietary Supplement | Mushroom extract; liquid |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 4, week 8, week 12, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | Febrile neutropenia is defined as absolute neutrophil count < 1.0 x 10^9/L and temperature > 38.3 degrees Celsius. | Baseline, week 4, week 8, week 12, week 16 |
| Change in neutrophil to lymphocyte ratio (NLR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Legacy | Contact | 613-792-1222 | 1 | mlegacy@thechi.ca |
| Dugald Seely | Contact | 613-792-1222 | 1 | dseely@thechi.ca |
| Name | Affiliation | Role |
|---|---|---|
| Adrienne Junek, MD | Centre for Health Innovation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Centre for Health Innovation | Recruiting | Ottawa | Ontario | K2P 0M7 | Canada |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Uncontrolled single arm clinical trial
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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.
| Baseline, week 4, week 8, week 12, week 16 |
| 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. | Baseline, week 4, week 8, week 12, week 16 |
| 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. | Baseline, week 4, week 8, week 12, week 16 |
| Changes in Quality of Life | 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. | Baseline, week 4, week 8, week 12, week 16 |
| Changes in hemoglobin A1c (HbA1c) | 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. | Baseline, week 4, week 8, week 12, week 16 |
| Incidence of adverse events | The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0. | 16 weeks |
| Incidence of dose reductions or delays in systemic therapy | 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. | 16 weeks. |
| Addition of new medications to combat neutropenia | 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. | 16 weeks |
| Canadian College of Naturopathic Medicine - Integrative Cancer Centre | Recruiting | Toronto | Ontario | M2K 1E2 | Canada |
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