Recruiting
Phase 2

Reishi Mushroom Extract

Sponsor:

Mayo Clinic

Code:

NCT06028022

Conditions

Estrogen Receptor-Positive Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mushroom Extract

Placebo Administration

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Estrogen Receptor-Positive Breast Carcinoma

Study ID

NCT06028022

Start date

Oct 18, 2023

Status verified date

Jun, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative
  • Fatigue ≥ 4/10
  • Currently post-menopausal (as defined by National Comprehensive Cancer Network (version 4.2024), taking any aromatase inhibitor in the curative setting and planning to be on such for at least 8 weeks after registration. \[Patients on concurrent ovarian suppression (such as with leuprolide acetate, goserelin) are allowed\]; CDK 4/6 inhibitors abemaciclib, ribociclib ARE allowed
  • Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated with chemotherapy)
  • On a stable dose of pain medications if pain medications are being regularly used. (i.e., no change in dosage in the past 30 days)
  • If on supplements, must be on stable dose with no plan to change; not on or planning any acupuncture or other specific supportive modalities for fatigue or AI arthralgias
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • White blood cell count (WBC) ≥ 3,000/mm\^3 (obtained ≤ 30 days prior to randomization)
  • Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to randomization)
  • Platelet count ≥ 100,000/mm\^3 (obtained ≤ 30 days prior to randomization)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization)
  • Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 1.2 x ULN (obtained ≤ 30 days prior to randomization)
  • Prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization)
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons on concurrent ovarian suppression only
  • Provide informed consent
  • Ability to complete questionnaires
  • Willing to return to enrolling institution during the active monitoring phase of the study
  • Patients who have had a recent surgery or procedure should be healed and cleared by their clinician and/or surgeon per local standards, prior to registration

Exclusion Criteria:

  • Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or active/untreated hepatitis
  • Allergy to mushrooms
  • On anticoagulation medication or aspirin or having a known bleeding disorder
  • On any specific medication for fatigue (e.g., methylphenidate)
  • Metastatic cancer diagnosis (history of nodal metastases is allowed)
  • Chronic steroid use, unless on physiologic replacement doses
  • Current use of any medical mushrooms
  • On medications for diabetes
  • History of symptomatic hypotension
  • Taking CYP3A4, CYP2D6 sensitive substrates which can be located at the following link:

https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems

  • Drugs which exhibit either >20% inhibition or >20% induction of CYP2E1 in vivo, such as: Acetaminophen, Dapsone, Enflurane, Halothane, Isoflurane, \& Theophylline
  • Taking olaparib
  • Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects:

  • Pregnant persons
  • Nursing persons
  • Persons on concurrent ovarian suppression who are unwilling to employ adequate contraception (e.g., hormonal methods, barrier methods, intrauterine device, abstinence)
  • Planned surgery or procedure during time on study and ≤ 14 days after last dose, due to bleeding risks

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (Reishi mushroom extract, placebo)

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.

experimental: Arm II (placebo, Reishi mushroom extract)

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.

Interventions

Mushroom Extract

Given Reishi mushroom extract PO

Placebo Administration

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in fatigue scores [ Time Frame: Baseline to end of four weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mina Hanna, MD

Essentia Health Baxter Clinic

Recruiting

Baxter, Minnesota, United States, 56425

Contacts

Bret E. Friday, M.D.

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, M.D.

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Jarrett Failing, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Jarrett Failing, MD

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Saint Mary's - Detroit Lakes Clinic

Recruiting

Detroit Lakes, Minnesota, United States, 56501

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Bret E. Friday, MD

218-786-3625ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Ely Clinic

Recruiting

Ely, Minnesota, United States, 55731

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Fosston

Recruiting

Fosston, Minnesota, United States, 56542

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Fairview Grand Itasca Clinic & Hospital

Recruiting

Grand Rapids, Minnesota, United States, 55744

Contacts

Aparna Basu, MD

218-362-6230marella.warner@fairview.org

Principal Investigator:

Aparna Basu, MD

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Fairview Range Medical Center

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Aparna Basu, MD

218-362-6230marella.warner@fairview.org

Principal Investigator:

Aparna Basu, MD

Essentia Health International Falls Clinic

Recruiting

International Falls, Minnesota, United States, 56649

Contacts

Bret E. Friday, M.D.

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, M.D.

Mayo Clinic Health Systems-Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Stephen D. Thome, MD

Essentia Health Moose Lake

Recruiting

Moose Lake, Minnesota, United States, 55767

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Essentia Health Park Rapids

Recruiting

Park Rapids, Minnesota, United States, 56470

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Fairview Northland Medical Center

Recruiting

Princeton, Minnesota, United States, 55731

Contacts

Aparna Basu, MD

218-362-6230marella.warner@fairview.org

Principal Investigator:

Aparna Basu, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Stacy D. D'Andre, M.D.

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Bret E. Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret E. Friday, MD

Sanford Thief River Falls Medical Center

Recruiting

Thief River Falls, Minnesota, United States, 56701

Contacts

Amit Panwalkar, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Amit Panwalkar, MD

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Bret Friday, MD

612-624-2620ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Sanford Worthington Medical Center

Recruiting

Worthington, Minnesota, United States, 56187

Contacts

Jonathan Bleeker, MD

jonathan.bleeker@sanfordhealth.org

Principal Investigator:

Jonathan Bleeker, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-16.