Clinical Trials

Inclusion Criteria

• Age ≥ 18 years.
• History of breast Cancer, 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.
• ECOG Performance Status (PS) 0, 1 or 2.
• Required Initial laboratory values obtained ≤ 30 days prior to randomization, including the following:
• • White blood cell count (WBC) ≥ 3,000/mm^3;
  • Hemoglobin ≥ 10 g/dL;
  • Platelet count ≥ 100,000/mm^3;
  • Total bilirubin ≤ 1.5 x ULN;
  • Alanine aminotransferase (ALT) or Aspartate transaminase (AST) ≤ 1.2 x ULN;
  • PT/aPTT ≤ 1.5 x ULN.
• 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 or CYP2E1 substrates.
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/30/23. Questions regarding updates should be directed to the study team contact.