Reishi Mushroom Extract for Fatigue And/or Arthralgias/myalgias in Patients with Breast Cancer on Aromatase Inhibitors

Description

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

Study Overview

Study Details

Study overview

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.

Reishi Mushroom Extract for Fatigue And/or Arthralgias in Patients with Breast Cancer on Aromatase Inhibitors: a Randomized Phase II MNCCTN Trial

Reishi Mushroom Extract for Fatigue And/or Arthralgias/myalgias in Patients with Breast Cancer on Aromatase Inhibitors

Condition
Estrogen Receptor-Positive Breast Carcinoma
Intervention / Treatment

-

Contacts and Locations

Albert Lea

Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States, 56007

Mankato

Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, United States, 56001

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Stacy D. D'Andre, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2025-10-16