Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Start Date
10/18/2023
Completion Date
9/15/2027
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.
Detailed Description
PRIMARY OBJECTIVE: 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Mushroom Extract
Placebo Administration
Quality-of-Life Assessment
Questionnaire Administration
Conditions
Locations
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
United States
Essentia Health Baxter Clinic
Baxter, Minnesota 56425
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
United States
Essentia Health Deer River Clinic
Deer River, Minnesota 56636
United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Essentia Health Ely Clinic
Ely, Minnesota 55731
United States
Essentia Health Fosston
Fosston, Minnesota 56542
United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota 55744
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Fairview Range Medical Center
Hibbing, Minnesota 55746
United States
Essentia Health International Falls Clinic
International Falls, Minnesota 56649
United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota 56001
United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota 55362
United States
Essentia Health Moose Lake
Moose Lake, Minnesota 55767
United States
Essentia Health Park Rapids
Park Rapids, Minnesota 56470
United States
Fairview Northland Medical Center
Princeton, Minnesota 55731
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
United States
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United States
Sanford Worthington Medical Center
Worthington, Minnesota 56187
United States