Reishi Mushroom Extract for Fatigue and Pain in Breast Cancer Patients
This study is looking at how well Reishi mushroom extract works to reduce fatigue and joint/muscle pain (arthralgias/myalgias) in women with estrogen receptor-positive (ER+) breast cancer. These women are currently taking aromatase inhibitors, a common breast cancer medication. Fatigue and pain are common side effects of these medications and can affect quality of life. Reishi mushrooms have been used for a long time to help with the immune system, stress, sleep, and fatigue. The study wants to see if Reishi mushroom extract can improve fatigue scores over four weeks. About 80 women are planned to join this study, but its current status is unclear.
- Study design
- This interventional study is designed to enroll 80 participants. It compares Reishi mushroom extract to a placebo (an inactive substance) to see which is more effective.
- What's involved
- Participants will take either Reishi mushroom extract or a placebo by mouth three times a day for four weeks, then switch to the other for another four weeks. They will also complete quality-of-life assessments and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes in fatigue scores from the beginning of the study to the end of four weeks of treatment.
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NCT06028022
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Recruiting
PHASE2Ages 18+InterventionalSupportive careMayo ClinicInvestigator-initiated
~80 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Mushroom ExtractPlacebo AdministrationQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
22 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fatigue scores
Measured over Baseline to end of four weeks
Conditions
Where it's being run
23 sites across 1 statesMinnesota23
Study leadership
- Stacy D. D'Andre, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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:
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
What this trial measures
- Change in fatigue scoresBaseline to end of four weeks
Based on a single item fatigue uniscale question. Will be compared between arms using a two-sided two-sample t-test assuming equal variances in each group.