Maitake for Integrative Cancer Care

Cancer Clinical Trial

— Maitake  

Official title:

Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323473
• Other study ID #: Maitake001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: The Canadian College of Naturopathic Medicine
• Contact: Mark Legacy
• Phone: 613-792-1222
• Email: mlegacy[@]thechi.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• Black Maitake Prothera
Mushroom extract; liquid

Locations

Country	Name	City	State
Canada	The Centre for Health Innovation	Ottawa	Ontario
Canada	Canadian College of Naturopathic Medicine - Integrative Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Baseline, week 4, week 8, week 12, week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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