Status:
RECRUITING
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Lead Sponsor:
Mayo Clinic
Conditions:
Estrogen Receptor-Positive Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of 1,000 mg three times daily (TID) of Reishi mushroom extracts as therapy for cancer-related fatigue measured by uniscale measurement at the end of fou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06028022
Start Date
October 18 2023
End Date
October 16 2026
Last Update
December 29 2025
Active Locations (23)
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1
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
2
Essentia Health Baxter Clinic
Baxter, Minnesota, United States, 56425
3
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
4
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401