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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other, Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patients who have had a recent surgery or procedure should be healed and cleared by their clinician and/or surgeon per local standards, prior to registration

Locations
United States
Minnesota
Mayo Clinic Health System in Albert Lea
RECRUITING
Albert Lea
Essentia Health Baxter Clinic
RECRUITING
Baxter
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Ely Clinic
RECRUITING
Ely
Essentia Health Fosston
RECRUITING
Fosston
Fairview Grand Itasca Clinic & Hospital
RECRUITING
Grand Rapids
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Fairview Range Medical Center
RECRUITING
Hibbing
Essentia Health International Falls Clinic
RECRUITING
International Falls
Mayo Clinic Health Systems-Mankato
RECRUITING
Mankato
MMCORC CentraCare Monticello Cancer Center
RECRUITING
Monticello
Essentia Health Moose Lake
RECRUITING
Moose Lake
Essentia Health Park Rapids
RECRUITING
Park Rapids
Fairview Northland Medical Center
RECRUITING
Princeton
Mayo Clinic in Rochester
RECRUITING
Rochester
Essentia Health Sandstone
RECRUITING
Sandstone
Sanford Thief River Falls Medical Center
RECRUITING
Thief River Falls
Essentia Health Virginia Clinic
RECRUITING
Virginia
Sanford Worthington Medical Center
RECRUITING
Worthington
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2026-10-16
Participants
Target number of participants: 80
Treatments
Experimental: Arm I (Reishi mushroom extract, placebo)
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.
Experimental: Arm II (placebo, Reishi mushroom extract)
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov