Maitake for Cancer

(Maitake Trial)

Recruiting at 1 trial location

Overseen By Mark Legacy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Canadian College of Naturopathic Medicine

Must be taking: Chemotherapy, CD4/6 inhibitors

Must not be taking: Hypoglycemics, Anticoagulants, Immune checkpoint inhibitors

Disqualifiers: Hematologic cancers, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Maitake, an edible mushroom, can boost the immune system when combined with standard cancer treatments like chemotherapy. Researchers aim to determine Maitake's effects on the immune system in people with cancer. Individuals with a confirmed cancer diagnosis who are receiving chemotherapy or CD4/6 inhibitors in Ontario, Canada, might be eligible to join the study. As a Phase 2 trial, this research measures how well Maitake works in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking hypoglycemic (blood sugar-lowering) or anticoagulant (blood-thinning) medications.

Is there any evidence suggesting that Maitake is likely to be safe for humans?

Research shows that Maitake, an edible mushroom, is generally safe to eat. Studies have explored its potential to boost the immune system and fight cancer cells. Although some evidence suggests Maitake might help against cancer, specific safety information for cancer patients remains limited.

Previous studies indicate that Maitake is well-tolerated, especially when consumed in normal food amounts. This phase of research examines how Maitake interacts with standard cancer treatments, and early evidence suggests safety in humans. The goal is to understand how Maitake affects people undergoing cancer treatment.

For those considering joining this study, it's important to know that while Maitake is generally considered safe, research is ongoing to fully understand its safety with cancer therapies. Always consult your doctor before joining any clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike the standard cancer treatments that primarily rely on chemotherapy and CD4/6 inhibitors, Black Maitake Prothera adds a unique twist by incorporating a natural mushroom-derived component into the treatment regimen. Researchers are excited about this because Maitake mushrooms are thought to have immune-boosting properties, potentially enhancing the body's ability to fight cancer alongside traditional therapies. This integrative approach could offer a novel mechanism of action, aiming to improve outcomes and reduce side effects compared to conventional treatments alone.

What evidence suggests that Maitake might be an effective treatment for cancer?

Research suggests that Maitake mushrooms, particularly the Black Maitake Prothera, might strengthen the immune system. Studies have found that these mushrooms could have cancer-fighting effects, especially for breast cancer, by enhancing the body's immune response. In both animal and human studies, Maitake improved immune function, which might help the body combat cancer. However, while the results are promising, the effectiveness of Maitake for people with cancer remains unclear. In this trial, researchers will administer Maitake alongside systemic chemotherapy and/or CD4/6 inhibitors to evaluate its potential benefits when used with standard cancer treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Adrienne Junek, MD

Principal Investigator

Centre for Health Innovation

Are You a Good Fit for This Trial?

This trial is for cancer patients interested in exploring the potential benefits of a medicinal mushroom called Maitake alongside their standard cancer treatment. Specific eligibility criteria are not provided.

Inclusion Criteria

Confirmed cancer diagnosis through biopsy or radiologic imaging

Currently receiving cancer treatment in Ontario, Canada

I am currently receiving chemotherapy or CD4/6 inhibitors.

Exclusion Criteria

I have not taken any mushroom supplements in the last 6 months.

I am currently on medication for blood sugar or blood thinning.

I am currently on immune checkpoint inhibitor therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Maitake alongside systemic chemotherapy and/or CD4/6 inhibitors

16 weeks

Visits at baseline, week 4, week 8, week 12, week 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Black Maitake Prothera

Trial Overview The study is testing Black Maitake Prothera, an edible mushroom known for its nutritional and possible immune-boosting properties, to see if it can improve immune function in those undergoing conventional cancer therapy.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors

Who Is Running the Clinical Trial?

The Canadian College of Naturopathic Medicine

Lead Sponsor

Trials

23

Recruited

2,600+

Published Research Related to This Trial

Several mushrooms, including Antrodia camphorata, Ganoderma lucidum, and Lentinula edodes, have shown anti-breast cancer activity in human clinical trials, indicating their potential as therapeutic agents.

The review highlights the mechanisms of action for these mushrooms, suggesting they may help inhibit cancer growth and support treatment strategies for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mushroom extracts and compounds with suppressive action on breast cancer: evidence from studies using cultured cancer cells, tumor-bearing animals, and clinical trials. Wong, JH., Ng, TB., Chan, HHL., et al.[2021]

A water-soluble extract of Maitake mushroom significantly inhibited the growth of four human gastric cancer cell lines, with the most substantial effect observed in TMK-1 cells, showing up to 90% inhibition after 3 days of treatment with 10% extract.

The extract induced apoptosis in TMK-1 cells through both caspase-3-dependent and -independent pathways, as evidenced by increased levels of cytochrome c and activation of caspase-3, suggesting potential antitumor effects against gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effects of a water-soluble extract from Maitake (Grifola frondosa) on human gastric cancer cell lines. Shomori, K., Yamamoto, M., Arifuku, I., et al.[2019]

In a clinical trial involving 15 dogs with lymphoma, Maitake PETfraction was well tolerated with minimal adverse effects, indicating a good safety profile for this treatment.

However, the treatment did not result in any significant reduction in tumor size, as no dogs showed a decrease in lymph node size of greater than 50%, and most dogs experienced disease progression within four weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mushroom-derived maitake PETfraction as single agent for the treatment of lymphoma in dogs. Griessmayr, PC., Gauthier, M., Barber, LG., et al.[2019]

Maitake D-Fraction Pro4X significantly prevented breast cancer development in female BALBc mice, blocking over 60% of tumor growth compared to control, indicating its potential as an effective anti-cancer agent.

The study also showed that Maitake D-Fraction Pro4X reduced tumor invasiveness and angiogenesis, while increasing overall survival, suggesting it may enhance immune response against tumors without harming normal cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maitake Pro4X has anti-cancer activity and prevents oncogenesis in BALBc mice. Roldan-Deamicis, A., Alonso, E., Brie, B., et al.[2021]

Chemical modification of maitake polysaccharide-peptides (MPSP) significantly enhances their anticancer properties, with phosphorylated MPSP showing the greatest efficacy in both in vivo and in vitro studies involving cancer cells.

All forms of modified MPSP demonstrated a significant adjuvant effect when combined with cyclophosphamide treatment in a rat model, indicating their potential as supportive therapies in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of in vitro and in vivo anticancer activities of polysaccharide peptide from Grifola frondosa by chemical modifications. Chan, JY., Chan, E., Chan, SW., et al.[2011]

Maitake mushrooms, particularly the MD-fraction extract, are recognized for their strong health benefits, especially as immunomodulating agents that may enhance cancer and HIV therapies.

These maitake extracts have also shown potential in helping manage conditions like high cholesterol, high blood pressure, and hepatitis, indicating their broad therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maitake extracts and their therapeutic potential. Mayell, M.[2020]

Medicinal mushrooms like Shiitake, Turkey Tail, and Scaly Wood show promise in cancer treatment by potentially preventing lymph node metastasis, prolonging survival, and reducing side effects from chemotherapy, based on a review of nine studies.

The review highlights the need for more rigorous research, including randomized controlled trials with larger sample sizes, to confirm these benefits and determine the most effective dosages for patients with high-mortality cancers such as gastric, breast, and colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. Dan, A., Swain, R., Belonce, S., et al.[2023]

In a study using MCF-7 human breast cancer cells, five types of mushrooms were found to significantly reduce cell proliferation by up to 33%, with maitake and oyster mushrooms being the most effective.

Maitake mushrooms not only suppressed cell growth but also significantly increased apoptosis (programmed cell death), suggesting they may have a stronger protective effect against breast cancer compared to other tested mushrooms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commonly consumed and specialty dietary mushrooms reduce cellular proliferation in MCF-7 human breast cancer cells. Martin, KR., Brophy, SK.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06323473

NCT06323473 | Maitake for Integrative Cancer Care Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators ...

2. withpower.com withpower.com/trial/phase-2-malignancies-6-2024-e9bd7

Maitake for Cancer · Recruiting Participants for Phase ... Studies have found that Maitake can be particularly effective against breast cancer and may also boost the immune system to help the body fight cancer more ...

3. degruyterbrill.com degruyterbrill.com/document/doi/10.1515/jcim-2025-0200/html?srsltid=AfmBOorAZ6_beFVCKpi7ddnNvauRkSL0lzQqSAGwGYbqfpGl1EOFfpPS

Natural Health Products Research Society of Canada ... Black maitake mushroom (Grifola frondosa), a well-tolerated NHP, has shown anticancer effects in breast cancer but remains largely unexplored in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3751581/

A phase I/II trial of a polysaccharide extract from Grifola ... A polysaccharide extract from Grifola frondosa (Maitake extract) showed immunomodulatory effects in preclinical studies and therefore the potential for clinical ...

5. nutraceuticalbusinessreview.com nutraceuticalbusinessreview.com/maitake-mushrooms-could-improve-cancer-patients-care-research

Maitake mushrooms could improve cancer patients' care, ... Maitake mushrooms could improve cancer patients' care, research shows. The combination care of Shogun Black Maitake includes products Prothera ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-560/maitake-mushroom

Maitake Mushroom - Uses, Side Effects, and More It contains chemicals that might help fight tumors, stimulate the immune system, and lower blood sugar levels.

7. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/maitake

Maitake It's generally safe to eat maitake in food. Talk ... Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects.

8. healthline.com healthline.com/health/food-nutrition/maitake-mushroom

Maitake Mushroom: Risks, Benefits, and More Maitake mushrooms may help the body fight cancer cells through three pathways: protecting healthy cells, preventing tumor spread, and inhibiting growth.