Trial reportJournal of cancer research and clinical oncology2009
A phase I/II trial of a polysaccharide extract from Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects.
Trial report in Journal of cancer research and clinical oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
56 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Bioactivity research inFrontiers in fungal biology · 2026Pooled it
- The Potential of Mushroom Extracts to Improve Chemotherapy Efficacy in Cancer Cells: A Systematic Review.Cells · 2024Pooled it
- Medicinal Mushroom Supplements in Cancer: A Systematic Review of Clinical Studies.Current oncology reports · 2023Pooled it
- Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.Cancer immunology, immunotherapy : CII · 2015Trial
- Review
- Medicinal Mushrooms and Their Bioactive Compounds: From Traditional Use to Therapeutic Potential.Molecules (Basel, Switzerland) · 2026Review
- The Inclusion of Dietary and Medicinal Mushrooms into Translational Oncology: Pros and Cons at the Molecular Level.International journal of molecular sciences · 2026Review
- Mushroom-derived polysaccharides in cancer immunotherapy: mechanisms, human evidence, and translational priorities.Frontiers in oncology · 2026Review
- The Role of Integrative Oncology in Patients Affected by Triple Negative Breast Cancer.Current oncology reports · 2025Review
- Beyond biologics: fungal polysaccharides as dual-function materials for nanomedicine.Nanomedicine (London, England) · 2025Review
- Review
- Medicinal Mushrooms in Metastatic Breast Cancer: What Is Their Therapeutic Potential as Adjuvant in Clinical Settings?Current issues in molecular biology · 2024Review
- Physicochemical Properties of Different Sulfated Polysaccharide Components fromJournal of fungi (Basel, Switzerland) · 2024Article
- Biologically active secondary metabolites from white-rot fungi.Frontiers in chemistry · 2024Review
- Anti-Cancer Potential of Edible/Medicinal Mushrooms in Breast Cancer.International journal of molecular sciences · 2023Review
- Integrating herbal medicine into oncology care delivery: development, implementation, and evaluation of a novel program.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Article
- Natural polysaccharides exert anti-tumor effects as dendritic cell immune enhancers.Frontiers in oncology · 2023Review
- The Health and Clinical Benefits of Medicinal Fungi.Advances in biochemical engineering/biotechnology · 2023Article
- Article
- CD3Ɛ immune restorative ability induced by Maitake Pro4x in immunosupressed BALBc mice.BMC research notes · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundCancer patients commonly use dietary supplements to "boost immune function". A polysaccharide extract from Grifola frondosa (Maitake extract) showed immunomodulatory effects in preclinical studies and therefore the potential for clinical use. Whether oral administration in human produces measurable immunologic effects, however, is unknown.
methodsIn a phase I/II dose escalation trial, 34 postmenopausal breast cancer patients, free of disease after initial treatment, were enrolled sequentially in five cohorts. Maitake liquid extract was taken orally at 0.1, 0.5, 1.5, 3, or 5 mg/kg twice daily for 3 weeks. Peripheral blood was collected at days -7, 0 (prior to the first dosing), 7, 14, and 21 for ex vivo analyses. The primary endpoints were safety and tolerability.
resultsNo dose-limiting toxicity was encountered. Two patients withdrew prior to completion of the study due to grade I possibly related side effects: nausea and joint swelling in one patient; rash and pruritus in the second. There was a statistically significant association between Maitake and immunologic function (p < 0.0005). Increasing doses of Maitake increased some immunologic parameters and depressed others; the dose-response curves for many endpoints were non-monotonic with intermediate doses having either immune enhancing or immune suppressant effects compared with both high and low doses.
conclusionsOral administration of a polysaccharide extract from Maitake mushroom is associated with both immunologically stimulatory and inhibitory measurable effects in peripheral blood. Cancer patients should be made aware of the fact that botanical agents produce more complex effects than assumed, and may depress as well as enhance immune function.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.