Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
NCT ID: NCT06028022
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2023-10-18
2026-10-16
Brief Summary
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Detailed Description
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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 four weeks.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of Reishi mushroom extracts as therapy for cancer-related arthralgias at the end of four weeks and four weeks after cross-over as measured by the Brief Pain index (BPI)-adapted for AI associated arthralgias.
II. To evaluate the effect of Reishi mushroom extracts on cancer-related quality of life (QOL), as measured by uniscale, at the end of four weeks and four weeks after cross-over.
III. To evaluate the efficacy of Reishi mushroom extracts on mood, as assessed by the World Health Organization Five Well-Being Index (WHO-5) item well-being scale, at the end of four weeks and four weeks after cross-over.
IV. To evaluate treatment toxicity between the two treatment arms, as measured by a patient symptom experience diary and weekly calls from the study team.
V. To evaluate the interest, knowledge, and acceptance of integrative treatments for cancer-related symptoms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Reishi mushroom extract orally (PO) TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (Reishi mushroom extract, placebo)
Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
Mushroom Extract
Given Reishi mushroom extract PO
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (placebo, Reishi mushroom extract)
Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
Mushroom Extract
Given Reishi mushroom extract PO
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Mushroom Extract
Given Reishi mushroom extract PO
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Stacy D. D'Andre, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Essentia Health Baxter Clinic
Baxter, Minnesota, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Ely Clinic
Ely, Minnesota, United States
Essentia Health Fosston
Fosston, Minnesota, United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Fairview Range Medical Center
Hibbing, Minnesota, United States
Essentia Health International Falls Clinic
International Falls, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, United States
Essentia Health Moose Lake
Moose Lake, Minnesota, United States
Essentia Health Park Rapids
Park Rapids, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Sanford Worthington Medical Center
Worthington, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Bret E. Friday, M.D.
Role: primary
Jarrett Failing, MD
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Aparna Basu, MD
Role: primary
Bret E. Friday, MD
Role: primary
Aparna Basu, MD
Role: primary
Bret E. Friday, M.D.
Role: primary
Clinical Trials Referral Office
Role: primary
Bret E. Friday, MD
Role: primary
Bret E. Friday, MD
Role: primary
Aparna Basu, MD
Role: primary
Clinical Trials Referral Office
Role: primary
Bret E. Friday, MD
Role: primary
Amit Panwalkar, MD
Role: primary
Bret Friday, MD
Role: primary
Jonathan Bleeker, MD
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-06578
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC221002
Identifier Type: OTHER
Identifier Source: secondary_id
23-005266
Identifier Type: OTHER
Identifier Source: secondary_id
MNCCTN032
Identifier Type: OTHER
Identifier Source: secondary_id
MC221002
Identifier Type: -
Identifier Source: org_study_id