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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative

• Fatigue ≥ 4/10

• Currently 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)

• 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 of childbearing potential only

• Provide written informed consent

• Ability to complete questionnaires

• Willing to return to enrolling institution during the active monitoring phase of the study

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 CDK4/6 inhibitors or olaparib

• Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects:

• Pregnant persons

• Nursing persons

• Persons of childbearing potential who are unwilling to employ adequate contraception