Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors

NCT06028022 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: MC221002NCI-2023-0657823-005266MNCCTN032
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 23

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 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

Estrogen Receptor-Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in fatigue scores

  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.

  Baseline to end of four weeks

Secondary Outcomes (3)

• Change in quality of life

  Baseline to the end of four weeks and four weeks after cross-over

• Change in arthralgias

  Baseline to the end of four weeks and four weeks after cross-over

• Incidence of adverse events

  Up to 30 days follow-up

Study Arms (2)

Arm I (Reishi mushroom extract, placebo)

EXPERIMENTAL

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.

Dietary Supplement: Mushroom Extract; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (placebo, Reishi mushroom extract)

EXPERIMENTAL

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.

Dietary Supplement: Mushroom Extract; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Mushroom Extract DIETARY_SUPPLEMENT

Given Reishi mushroom extract PO

Also known as: Agaricus bisporus Extract, Cultivated Mushroom

Arm I (Reishi mushroom extract, placebo); Arm II (placebo, Reishi mushroom extract)

Placebo Administration DRUG

Given PO

Arm I (Reishi mushroom extract, placebo); Arm II (placebo, Reishi mushroom extract)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Reishi mushroom extract, placebo); Arm II (placebo, Reishi mushroom extract)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Reishi mushroom extract, placebo); Arm II (placebo, Reishi mushroom extract)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (23)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

RECRUITING

Essentia Health Baxter Clinic

Baxter, Minnesota, 56425, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Essentia Health Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

RECRUITING

Essentia Health Ely Clinic

Ely, Minnesota, 55731, United States

RECRUITING

Essentia Health Fosston

Fosston, Minnesota, 56542, United States

RECRUITING

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, 55744, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

RECRUITING

Essentia Health International Falls Clinic

International Falls, Minnesota, 56649, United States

RECRUITING

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

RECRUITING

MMCORC CentraCare Monticello Cancer Center

Monticello, Minnesota, 55362, United States

COMPLETED

Essentia Health Moose Lake

Moose Lake, Minnesota, 55767, United States

RECRUITING

Essentia Health Park Rapids

Park Rapids, Minnesota, 56470, United States

RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, 55731, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

RECRUITING

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

Sanford Worthington Medical Center

Worthington, Minnesota, 56187, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Stacy D. D'Andre, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (23)