Phase
Condition
Muscle Pain
Arthritis And Arthritic Pain
Treatment
Mushroom
Placebo Administration
Questionnaire Administration
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
History of breast cancer, estrogen receptor positive (ER+), Her 2 positive ornegative
Fatigue ≥ 4/10
Currently post-menopausal (as defined by National Comprehensive Cancer Network (version 4.2024), taking any aromatase inhibitor in the curative setting andplanning to be on such for at least 8 weeks after registration. (Patients onconcurrent ovarian suppression [such as with leuprolide acetate, goserelin] areallowed) ; CDK 4/6 inhibitors abemaciclib, ribociclib ARE allowed
Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated withchemotherapy)
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 planningany acupuncture or other specific supportive modalities for fatigue or AIarthralgias
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 torandomization)
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 torandomization)
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 onconcurrent ovarian suppression only
Provide informed consent
Ability to complete questionnaires
Willing to return to enrolling institution during the active monitoring phase of thestudy
Exclusion
Exclusion Criteria:
Other known uncontrolled medical conditions causing fatigue such as untreatedthyroid 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 followinglink:
https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-exampl es-drugs-interact-cyp-enzymes-and-transporter-systems
Drugs which exhibit either >20% inhibition or >20% induction of CYP2E1 in vivo, suchas: Acetaminophen, Dapsone, Enflurane, Halothane, Isoflurane, & Theophylline
Taking olaparib
Any of the following because this study involves an agent that has unknowngenotoxic, mutagenic and teratogenic effects:
Pregnant persons
Nursing persons
Persons on concurrent ovarian suppression who are unwilling to employ adequatecontraception (e.g., hormonal methods, barrier methods, intrauterine device,abstinence)
Study Design
Study Description
Connect with a study center
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
United StatesActive - Recruiting
Essentia Health Baxter Clinic
Baxter, Minnesota 56425
United StatesActive - Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United StatesActive - Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
United StatesActive - Recruiting
Essentia Health Deer River Clinic
Deer River, Minnesota 56636
United StatesActive - Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
United StatesActive - Recruiting
Essentia Health Cancer Center
Duluth, Minnesota 55805
United StatesActive - Recruiting
Essentia Health Ely Clinic
Ely, Minnesota 55731
United StatesActive - Recruiting
Essentia Health Fosston
Fosston, Minnesota 56542
United StatesActive - Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United StatesActive - Recruiting
Essentia Health International Falls Clinic
International Falls, Minnesota 56649
United StatesActive - Recruiting
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota 56001
United StatesActive - Recruiting
Essentia Health Moose Lake
Moose Lake, Minnesota 55767
United StatesActive - Recruiting
Essentia Health Park Rapids
Park Rapids, Minnesota 56470
United StatesActive - Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Essentia Health Sandstone
Sandstone, Minnesota 55072
United StatesActive - Recruiting
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
United StatesActive - Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United StatesActive - Recruiting
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