Black Maitake Prothera
Dietary SupplementMushroom extract; liquid
Other names: Grifola Fondosa, Maitake
NCT Number: NCT06323473
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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Request InfoHealthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
Mushroom extract; liquid
Other names: Grifola Fondosa, Maitake
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
The Canadian College of Naturopathic Medicine
Other
Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy
Acronym: Maitake
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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