Actively Recruiting
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Led by Mayo Clinic · Updated on 2025-12-29
80
Participants Needed
23
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of breast cancer that is estrogen receptor positive (ER+), HER2 positive or negative
- Fatigue score of 4 or higher on a 0-10 scale
- Post-menopausal status as defined by National Comprehensive Cancer Network guidelines
- Currently taking an aromatase inhibitor for breast cancer treatment and planning to continue for at least 8 weeks
- Patients on concurrent ovarian suppression or CDK 4/6 inhibitors (abemaciclib, ribociclib) are allowed
- Last chemotherapy treatment at least 90 days before enrollment if applicable
- Stable dose of pain medications for at least 30 days prior if used
- Stable dose of supplements with no planned changes and no acupuncture or other fatigue or arthralgia therapies planned
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- White blood cell count of at least 3,000/mm3 within 30 days before enrollment
- Hemoglobin level of at least 10 g/dL within 30 days before enrollment
- Platelet count of at least 100,000/mm3 within 30 days before enrollment
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 30 days before enrollment
- Alanine aminotransferase (ALT) or aspartate transaminase (AST) less than or equal to 1.2 times the upper limit of normal within 30 days before enrollment
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 times the upper limit of normal within 30 days before enrollment
- Negative pregnancy test within 7 days before registration for those on ovarian suppression
- Ability to provide informed consent and complete questionnaires
- Willingness to return to the study site during active monitoring
- Any recent surgery or procedure must be healed and cleared by a clinician before enrollment
You will not qualify if you...
- Other uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or untreated hepatitis
- Allergy to mushrooms
- Use of anticoagulation medications, aspirin, or having a known bleeding disorder
- Use of specific medications for fatigue such as methylphenidate
- Diagnosis of metastatic cancer (patients with nodal metastases history allowed)
- Chronic steroid use except physiologic replacement doses
- Current use of any medicinal mushrooms
- Use of medications for diabetes
- History of symptomatic low blood pressure (hypotension)
- Use of drugs that interact with CYP3A4, CYP2D6, or those that inhibit or induce CYP2E1 enzymes significantly
- Use of olaparib
- Pregnancy, nursing, or unwillingness to use adequate contraception if on ovarian suppression
- Planned surgery or procedure during study treatment period and within 14 days after last dose due to bleeding risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Actively Recruiting
2
Essentia Health Baxter Clinic
Baxter, Minnesota, United States, 56425
Actively Recruiting
3
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
4
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
5
Essentia Health Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
6
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States, 56501
Actively Recruiting
7
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
8
Essentia Health Ely Clinic
Ely, Minnesota, United States, 55731
Actively Recruiting
9
Essentia Health Fosston
Fosston, Minnesota, United States, 56542
Actively Recruiting
10
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, United States, 55744
Actively Recruiting
11
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
12
Fairview Range Medical Center
Hibbing, Minnesota, United States, 55746
Actively Recruiting
13
Essentia Health International Falls Clinic
International Falls, Minnesota, United States, 56649
Actively Recruiting
14
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
15
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, United States, 55362
Completed
16
Essentia Health Moose Lake
Moose Lake, Minnesota, United States, 55767
Actively Recruiting
17
Essentia Health Park Rapids
Park Rapids, Minnesota, United States, 56470
Actively Recruiting
18
Fairview Northland Medical Center
Princeton, Minnesota, United States, 55731
Actively Recruiting
19
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
21
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States, 56701
Actively Recruiting
22
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
23
Sanford Worthington Medical Center
Worthington, Minnesota, United States, 56187
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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