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

Recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Reishi mushroom extract can reduce fatigue and joint or muscle pain in breast cancer patients taking aromatase inhibitors. These symptoms commonly affect patients on this medication and can significantly impact daily life. Participants will either take the Reishi extract first and then a placebo, or vice versa. The trial seeks post-menopausal individuals with breast cancer who experience significant fatigue and are currently on an aromatase inhibitor for treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Reishi mushroom extract is likely to be safe for humans?

Research has shown that Reishi mushroom extract is generally safe for people. In previous studies with cancer patients, no serious side effects were reported. For instance, one study found that Reishi mushroom extract helped reduce cancer-related tiredness without causing major problems, indicating it is usually well-tolerated.

When taken by mouth, Reishi mushroom extract is possibly safe for up to a year. However, like any treatment, some people might experience mild side effects such as an upset stomach or dry mouth.

Overall, current evidence suggests that Reishi mushroom extract is safe for people, especially during the short time frame typical of clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Reishi mushroom extract for breast cancer-related fatigue and joint pain because it offers a natural alternative to current treatments, which typically include medications like NSAIDs and corticosteroids. Unlike these standard options that mainly focus on reducing inflammation or blocking pain signals, Reishi mushroom extract is believed to have potential immune-modulating and anti-inflammatory properties derived from its active compounds, such as polysaccharides and triterpenoids. This could provide a holistic approach to managing symptoms by potentially enhancing overall well-being and energy levels, which is particularly appealing for patients seeking complementary or integrative therapies.

What evidence suggests that Reishi mushroom extract might be an effective treatment for fatigue and joint pain in breast cancer patients?

Research has shown that Reishi mushroom extract might alleviate symptoms like tiredness and joint pain in breast cancer patients. In this trial, participants will receive either Reishi mushroom extract or a placebo. A study with patients undergoing hormone therapy found that those who took Reishi spore powder experienced noticeable physical improvement. This finding suggests that Reishi mushroom could help reduce cancer-related tiredness. Although Reishi has not been specifically studied for joint pain from certain cancer medications, it has been used to improve quality of life and reduce stress and tiredness. These benefits make it a promising option for managing these symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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

Your blood clotting time is within the normal range.

Exclusion Criteria

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate contraception

I am taking medication for diabetes.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06028022

Reishi Mushroom Extract for Fatigue and/or Arthralgias ... Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614793/

Symptom improvements and adverse effects with Reishi ... Spore powder of ganoderma lucidum improves cancer-related fatigue in breast cancer patients undergoing endocrine therapy: a pilot clinical trial ...

3. withpower.com withpower.com/trial/phase-2-breast-neoplasms-9-2023-0b8b0

Reishi Mushroom Extract for Breast Cancer-Related ... In a pilot study involving 48 breast cancer patients undergoing endocrine therapy, spore powder of Ganoderma lucidum significantly improved physical well-being ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20555252

Reishi Mushroom for Fatigue And/or Arthralgias ... The purpose of this study is to evaluate the effect of Reishi mushroom extracts on aromatase-inhibitor toxicities, specifically fatigue, and arthralgias, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3236089/

Spore Powder of Ganoderma lucidum Improves Cancer ... This pilot study suggests that spore powder of Ganoderma lucidum may have beneficial effects on cancer-related fatigue and quality of life in breast cancer ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-905/reishi-mushroom

Reishi Mushroom - Uses, Side Effects, and More When taken by mouth: Reishi mushroom extract is possibly safe when used for up to one year. Powdered whole reishi mushroom is possibly safe when used for up to ...