Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Mushroom Extract
- Placebo Administration
- Quality-of-Life Assessment
- Questionnaire Administration
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
23Mayo Clinic Health System in Albert Lea56007, Albert LeaMinnesota, United States
Essentia Health Baxter Clinic56425, BaxterMinnesota, United States
Sanford Joe Lueken Cancer Center56601, BemidjiMinnesota, United States
Essentia Health Saint Joseph's Medical Center56401, BrainerdMinnesota, United States
Sponsors and collaborators
Mayo Clinic
Lead sponsor
Source ClinicalTrials.gov