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

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the treatment Maitake for Cancer?

Research shows that Maitake mushrooms, including extracts like Maitake D-Fraction, can help fight cancer by slowing down the growth of cancer cells and even causing them to die. 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 effectively. ^{1 2 3 4 5}

Is Maitake mushroom safe for human use?

While there is evidence that Maitake mushroom extracts have potential anticancer effects, the available research does not provide specific safety data for humans. More studies are needed to determine its safety profile in human subjects. ^{1 3 4 5 6}

How does the Maitake treatment differ from other cancer treatments?

Maitake, derived from the Grifola frondosa mushroom, is unique because it contains polysaccharide compounds like the D-fraction and MD-fraction, which have shown promise in boosting the immune system and potentially preventing cancer growth. Unlike traditional cancer treatments, Maitake is a natural extract that may selectively target tumor cells without harming normal cells. ^{1 4 5 7 8}

Research Team

Adrienne Junek, MD

Principal Investigator

Centre for Health Innovation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Germany 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mushroom-derived maitake PETfraction as single agent for the treatment of lymphoma in dogs. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Maitake Pro4X has anti-cancer activity and prevents oncogenesis in BALBc mice. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Antitumor effects of a water-soluble extract from Maitake (Grifola frondosa) on human gastric cancer cell lines. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Enhancement of in vitro and in vivo anticancer activities of polysaccharide peptide from Grifola frondosa by chemical modifications. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Maitake extracts and their therapeutic potential. [2020]