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RECRUITING
NCT06028022
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-10-18

Completion Date

2026-10-16

Last Updated

2025-12-29

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Mushroom Extract

Given Reishi mushroom extract PO

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire 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