Clinical trial NCT06323473: Maitake for Integrative Cancer Care
Official title: Maitake for Integrative Cancer Care: an Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Keywords: Chemotherapy
Maitake
Integrative Care
Integrative Medicine
Targeted Therapy
Neutrophil
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled single arm clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in absolute neutrophil count
timeFrame: Baseline, week 4, week 8, week 12, week 16
Secondary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in neutrophil to lymphocyte ratio (NLR)
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in platelet to lymphocyte ratio (PLR)
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in high-sensitivity C-reactive protein (CRP)
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Changes in Quality of Life
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Changes in hemoglobin A1c (HbA1c)
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Incidence of adverse events
timeFrame: 16 weeks
measure: Incidence of dose reductions or delays in systemic therapy
timeFrame: 16 weeks.
measure: Addition of new medications to combat neutropenia
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Centre for Health Innovation
state: Ontario
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine - Integrative Cancer Centre
state: Ontario
Study officials:
affiliation: Centre for Health Innovation
name: Adrienne Junek, MD
role: PRINCIPAL_INVESTIGATOR
References: