RecruitingPhase 2NCT06028022

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

Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial

Sponsor

Mayo Clinic

Enrollment

80 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Estrogen Receptor-Positive Breast Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an extract from reishi mushrooms can help reduce fatigue and joint/muscle pain in women with hormone receptor-positive breast cancer who are taking aromatase inhibitors — a type of hormone-blocking medication. Fatigue and joint pain are very common side effects that often lead people to stop their medication. **You may be eligible if...** - You are 18 or older with estrogen receptor-positive breast cancer (HER2 positive or negative) - You are post-menopausal and currently taking an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane) - You are experiencing fatigue rated at 4 out of 10 or higher - Your breast cancer is not metastatic (no distant spread) **You may NOT be eligible if...** - You are allergic to mushrooms - You take blood thinners (anticoagulants) or regular aspirin - You take certain medications that interact with the mushroom extract (CYP3A4/2D6 substrates) - You have another condition causing fatigue (e.g., untreated thyroid disease, active depression) - You are currently using any medical mushroom supplement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMushroom Extract

Given Reishi mushroom extract PO

DRUGPlacebo Administration

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Locations(23)

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

View Full Details on ClinicalTrials.gov

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NCT06028022

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