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Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors

RecruitingPhase 2

Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Mayo Clinic · Participants: 80 · Started: Oct 18, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06028022

Locations in the U.S.

MinnesotaMayo Clinic Health System in Albert Lea, Albert Lea
Essentia Health Baxter Clinic, Baxter
Sanford Joe Lueken Cancer Center, Bemidji
Essentia Health Saint Joseph's Medical Center, Brainerd
Essentia Health Deer River Clinic, Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes
Essentia Health Cancer Center, Duluth
Essentia Health Ely Clinic, Ely
Essentia Health Fosston, Fosston
Fairview Grand Itasca Clinic & Hospital, Grand Rapids
Essentia Health Hibbing Clinic, Hibbing
Fairview Range Medical Center, Hibbing
Essentia Health International Falls Clinic, International Falls
Mayo Clinic Health Systems-Mankato, Mankato
Essentia Health Moose Lake, Moose Lake
Essentia Health Park Rapids, Park Rapids
Fairview Northland Medical Center, Princeton
Mayo Clinic in Rochester, Rochester
Essentia Health Sandstone, Sandstone
Sanford Thief River Falls Medical Center, Thief River Falls
Essentia Health Virginia Clinic, Virginia
Sanford Worthington Medical Center, Worthington

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.