Reishi Mushroom Extract for Breast Cancer-Related Fatigue and Joint Pain

Recruiting at 19 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Aromatase inhibitors

Must not be taking: Anticoagulants, Aspirin, Diabetes medications, others

Disqualifiers: Uncontrolled thyroid disease, Depression, Fibromyalgia, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but have been shown to improve quality of life, muscular strength, pain, and flexibility. Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.

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 must be on a stable dose of any pain medications or supplements without plans to change them. Certain medications, like those for diabetes or specific drugs that interact with liver enzymes, are not allowed.

What data supports the effectiveness of the treatment Reishi Mushroom Extract for breast cancer-related fatigue and joint pain?

Research suggests that Ganoderma lucidum, a component of Reishi Mushroom Extract, may help reduce cancer-related fatigue and improve quality of life in breast cancer patients undergoing endocrine therapy. Additionally, medicinal mushrooms, including Ganoderma lucidum, have shown potential benefits in improving immune function and reducing adverse effects of conventional cancer treatments. ^{1 2 3 4 5}

Is Reishi Mushroom Extract safe for humans?

Research suggests that Reishi Mushroom Extract, also known as Ganoderma lucidum, is generally safe for humans. In studies involving cancer patients, no serious adverse effects were reported, although some mild gastrointestinal reactions and a decrease in platelet count were noted in a few cases. ^{1 2 5 6 7}

How does the Reishi Mushroom Extract treatment differ from other treatments for breast cancer-related fatigue and joint pain?

Reishi Mushroom Extract is unique because it is a natural supplement derived from Ganoderma lucidum, traditionally used in Asian medicine, and it may help reduce fatigue and improve quality of life in breast cancer patients without significant side effects. Unlike conventional treatments, it works by potentially modulating the immune system and reducing inflammation, offering a complementary approach to managing symptoms. ^{1 6 8 9 10}

Research Team

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults over 18 with breast cancer who are experiencing fatigue and joint/muscle pain while on aromatase inhibitors. They should have finished chemotherapy at least 90 days ago, have a stable blood count, not be pregnant or nursing, and willing to use contraception if of childbearing potential. Exclusions include metastatic cancer diagnosis, chronic steroid use (except replacement doses), mushroom allergies, uncontrolled conditions causing fatigue, certain medication users including anticoagulants and specific enzyme substrates.

Inclusion Criteria

Your hemoglobin level is at least 10 grams per deciliter within the past 30 days before starting the study.

I am 18 years old or older.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate contraception

I am taking medication for diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Reishi mushroom extract or placebo orally three times daily for 4 weeks, followed by a crossover to the alternate treatment for another 4 weeks

8 weeks

Weekly calls from the study team

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Reishi Mushroom Extract

Trial Overview The study examines the effectiveness of Reishi mushroom extract in reducing fatigue and joint/muscle pain in patients taking aromatase inhibitors for breast cancer treatment. Participants will either receive the mushroom extract or a placebo while their quality of life is assessed through questionnaires.

Participant Groups

Group I: Arm II (placebo, Reishi mushroom extract) Experimental Treatment 4 Interventions

Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (Reishi mushroom extract, placebo) Experimental Treatment 4 Interventions

Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a pilot study involving 48 breast cancer patients undergoing endocrine therapy, spore powder of Ganoderma lucidum significantly improved physical well-being and reduced fatigue after 4 weeks of treatment.

Patients taking Ganoderma lucidum also experienced lower levels of anxiety and depression, improved quality of life, and no serious adverse effects, suggesting it may be a safe and effective intervention for managing cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spore Powder of Ganoderma lucidum Improves Cancer-Related Fatigue in Breast Cancer Patients Undergoing Endocrine Therapy: A Pilot Clinical Trial. Zhao, H., Zhang, Q., Zhao, L., et al.[2022]

Culinary and medicinal mushrooms, particularly Ganoderma lucidum and Grifola frondosa, show promising anticancer properties based on epidemiological studies and in vitro research, suggesting they may help protect against gastrointestinal and breast cancers.

There is a need for future randomized controlled trials to better understand the clinical effects of these mushrooms on cancer treatment outcomes, including their impact on long-term survival, immune function, and quality of life in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B-glucans from Grifola frondosa and Ganoderma lucidum in breast cancer: an example of complementary and integrative medicine. Rossi, P., Difrancia, R., Quagliariello, V., et al.[2019]

An extract from the spores of Ganoderma lucidum (ESG) showed significant anticancer effects in a mouse model of breast cancer, effectively suppressing tumor growth and enhancing the immune response by increasing cytotoxic T cell populations.

ESG also downregulated immune checkpoints like PD-1 and CTLA-4, which helps restore T cell function, suggesting its potential as a natural adjuvant in breast cancer treatment by improving immune system activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor Activity of Extract From the Sporoderm-Breaking Spore of Ganoderma lucidum: Restoration on Exhausted Cytotoxic T Cell With Gut Microbiota Remodeling. Su, J., Su, L., Li, D., et al.[2020]

In a study using a triple-negative breast cancer mouse model, an orally administered blend of medicinal mushrooms rich in β-glucans significantly reduced the density of cerebellar metastases by about 50%, indicating its potential as an effective anti-cancer treatment.

The medicinal mushroom blend not only inhibited metastasis but also regulated key genes involved in apoptosis and cell proliferation, suggesting it could be a promising adjuvant treatment alongside conventional therapies for managing brain metastases in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fighting secondary triple-negative breast cancer in cerebellum: A powerful aid from a medicinal mushrooms blend. De Luca, F., Roda, E., Ratto, D., et al.[2023]

A review of eight randomized controlled trials involving various medicinal mushrooms suggests they may improve quality of life and reduce side effects in cancer patients undergoing conventional treatment.

While some studies indicated potential benefits in immune function and antitumor activity, the overall methodological quality was low, and there is a pressing need for more rigorous research to assess safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of Medicinal Mushrooms in Integrative Oncology: A Narrative Review. Jeitler, M., Michalsen, A., Frings, D., et al.[2021]

Aqueous extracts from different species of Ganoderma, particularly G. tsugae, significantly inhibited the proliferation of human breast cancer cells (MCF-7 and MDA-MB-231) without harming normal mammary epithelial cells, indicating their potential as safe antitumor agents.

The study found that the stipes (stems) of Ganoderma species exhibited the strongest antitumor effects and immunomodulatory activities, suggesting that this part of the fruiting body should be included in extracts for enhanced therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative studies of various ganoderma species and their different parts with regard to their antitumor and immunomodulating activities in vitro. Yue, GG., Fung, KP., Tse, GM., et al.[2014]

The medicinal mushroom Ganoderma lucidum (GL) enhances the effectiveness of the chemotherapy drug paclitaxel in colorectal cancer cells, promoting cell death and inhibiting tumor growth without being toxic at the tested concentrations.

GL works by suppressing inflammation pathways regulated by NF-κB, which are linked to cancer progression, and activates tumor suppressor genes, suggesting it could be a beneficial adjunct therapy for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory activity of medicinal mushroom Ganoderma lucidum on colorectal cancer by attenuating inflammation. Liu, MM., Liu, T., Yeung, S., et al.[2022]

Ganoderma lucidum (Reishi) has shown potential anticancer activity by inhibiting key transcription factors (NF-kappaB and AP-1), which reduces the expression of proteins that promote cancer cell invasiveness.

The mushroom also suppresses cell adhesion and migration in aggressive breast and prostate cancer cells, suggesting it could be a beneficial dietary supplement for alternative cancer therapies, although its biological activity may vary by source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ganoderma lucidum (Reishi) in cancer treatment. Sliva, D.[2006]

An alcohol extract from the spores of the medicinal mushroom Ganoderma lucidum was found to inhibit the growth of human umbilical vein endothelial cells and MDA-MB231 breast cancer cells in vitro.

The ethyl acetate fraction of this extract showed a dose-dependent inhibition of both cell lines, indicating potential anti-tumor and anti-angiogenic properties of Ganoderma lucidum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ganoderma lucidum spore extract inhibits endothelial and breast cancer cells in vitro. Lu, QY., Sartippour, MR., Brooks, MN., et al.[2015]

Aqueous extracts of the shiitake mushroom (Lentinula edodes) showed direct cytotoxic effects on MCF-7 human breast cancer cells, with low IC(50) values indicating effective inhibition of cancer cell growth, while sparing normal cells.

Both fruit body and mycelial extracts of shiitake enhanced the proliferation of rat thymocytes, demonstrating immunostimulatory properties that could support their use as adjuvants in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro cytostatic and immunomodulatory properties of the medicinal mushroom Lentinula edodes. Israilides, C., Kletsas, D., Arapoglou, D., et al.[2021]

References

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

Spore Powder of Ganoderma lucidum Improves Cancer-Related Fatigue in Breast Cancer Patients Undergoing Endocrine Therapy: A Pilot Clinical Trial. [2022]

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

B-glucans from Grifola frondosa and Ganoderma lucidum in breast cancer: an example of complementary and integrative medicine. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Antitumor Activity of Extract From the Sporoderm-Breaking Spore of Ganoderma lucidum: Restoration on Exhausted Cytotoxic T Cell With Gut Microbiota Remodeling. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Fighting secondary triple-negative breast cancer in cerebellum: A powerful aid from a medicinal mushrooms blend. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Significance of Medicinal Mushrooms in Integrative Oncology: A Narrative Review. [2021]

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

Comparative studies of various ganoderma species and their different parts with regard to their antitumor and immunomodulating activities in vitro. [2014]

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

Inhibitory activity of medicinal mushroom Ganoderma lucidum on colorectal cancer by attenuating inflammation. [2022]

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

Ganoderma lucidum (Reishi) in cancer treatment. [2006]

9. Greece pubmed.ncbi.nlm.nih.gov

Ganoderma lucidum spore extract inhibits endothelial and breast cancer cells in vitro. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

In vitro cytostatic and immunomodulatory properties of the medicinal mushroom Lentinula edodes. [2021]