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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Reishi mushroom extract helps with tiredness and joint or muscle pain in people with breast cancer. It is for adults taking aromatase inhibitors, medicines that lower estrogen, who have tiredness rated at least 4 out of 10.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and have a history of breast cancer that grows in response to estrogen. Either HER2 status is allowed.
- Have tiredness rated at least 4 out of 10.
- Be past menopause under the study rules and taking an aromatase inhibitor as part of treatment meant to cure the cancer. Plan to keep taking it for at least 8 weeks after signing up. Medicines that stop the ovaries from working, abemaciclib, and ribociclib are allowed.
- If you had chemotherapy, your last treatment must be at least 90 days before assignment to a study group. Any recent surgery or procedure must be healed and cleared by your clinician.
- If you regularly take pain medicine, the dose must not have changed for 30 days. Supplement doses must stay the same. You must not use or plan acupuncture or other special treatments for tiredness or pain caused by aromatase inhibitors.
- Be able to care for yourself and be out of bed or a chair for at least half the waking day. Blood tests within 30 days before group assignment must meet the study's blood cell, liver, and clotting limits.
- If taking medicine to stop the ovaries from working, have a negative pregnancy test within 7 days before signing up.
- Agree to join after learning about the study, be able to fill out surveys, and be willing to return to the study site for monitoring.
Who can't join
- Have another uncontrolled health problem that causes tiredness, such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, immune system disease, or active or untreated hepatitis.
- Have a mushroom allergy or currently use medicinal mushrooms.
- Take blood thinners or aspirin, have a bleeding disorder, or plan surgery or a procedure during the study or within 14 days after the last dose.
- Take medicine specifically for tiredness, diabetes medicine, or long-term steroids other than doses used to replace hormones your body needs.
- Have cancer that has spread to distant parts of the body. Past spread to lymph nodes is allowed.
- Have a history of low blood pressure that causes symptoms.
- Take olaparib or certain medicines affected by liver enzymes, which help break down drugs. These include certain CYP3A4 or CYP2D6 medicines and drugs that change CYP2E1 activity by more than 20%, such as acetaminophen, dapsone, enflurane, halothane, isoflurane, or theophylline.
- Be pregnant or breastfeeding, or be unwilling to use adequate birth control while taking medicine to stop the ovaries from working.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 * 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 Exclusion Criteria: * 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: https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems * 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) * Planned surgery or procedure during time on study and ≤ 14 days after last dose, due to bleeding risks
Study sites (23)
MN
- Mayo Clinic Health System in Albert Lea · Albert Lea, MN 56007Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduMina Hanna, MD · Principal investigatorMore trials in Albert Lea
- Essentia Health Baxter Clinic · Baxter, MN 56425Bret E. Friday, M.D. · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, M.D. · Principal investigatorMore trials in Baxter
- Sanford Joe Lueken Cancer Center · Bemidji, MN 56601Jarrett Failing, MD · Study contact · 612-624-2620 · ccinfo@umn.eduJarrett Failing, MD · Principal investigatorMore trials in Bemidji
- Essentia Health Saint Joseph's Medical Center · Brainerd, MN 56401Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Brainerd
- Essentia Health Deer River Clinic · Deer River, MN 56636Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Deer River
- Essentia Health Saint Mary's - Detroit Lakes Clinic · Detroit Lakes, MN 56501Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Detroit Lakes
- Essentia Health Cancer Center · Duluth, MN 55805Bret E. Friday, MD · Study contact · 218-786-3625 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Duluth
- Essentia Health Ely Clinic · Ely, MN 55731Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Ely
- Essentia Health Fosston · Fosston, MN 56542Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Fosston
- Fairview Grand Itasca Clinic & Hospital · Grand Rapids, MN 55744Aparna Basu, MD · Study contact · 218-362-6230 · marella.warner@fairview.orgAparna Basu, MD · Principal investigatorMore trials in Grand Rapids
- Essentia Health Hibbing Clinic · Hibbing, MN 55746Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Hibbing
- Fairview Range Medical Center · Hibbing, MN 55746Aparna Basu, MD · Study contact · 218-362-6230 · marella.warner@fairview.orgAparna Basu, MD · Principal investigatorMore trials in Hibbing
- Essentia Health International Falls Clinic · International Falls, MN 56649Bret E. Friday, M.D. · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, M.D. · Principal investigatorMore trials in International Falls
- Mayo Clinic Health Systems-Mankato · Mankato, MN 56001Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduStephen D. Thome, MD · Principal investigatorMore trials in Mankato
- MMCORC CentraCare Monticello Cancer Center · Monticello, MN 55362More trials in Monticello
- Essentia Health Moose Lake · Moose Lake, MN 55767Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Moose Lake
- Essentia Health Park Rapids · Park Rapids, MN 56470Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Park Rapids
- Fairview Northland Medical Center · Princeton, MN 55731Aparna Basu, MD · Study contact · 218-362-6230 · marella.warner@fairview.orgAparna Basu, MD · Principal investigatorMore trials in Princeton
- Mayo Clinic in Rochester · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduStacy D. D'Andre, M.D. · Principal investigatorMore trials in Rochester
- Essentia Health Sandstone · Sandstone, MN 55072Bret E. Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret E. Friday, MD · Principal investigatorMore trials in Sandstone
- Sanford Thief River Falls Medical Center · Thief River Falls, MN 56701Amit Panwalkar, MD · Study contact · 612-624-2620 · ccinfo@umn.eduAmit Panwalkar, MD · Principal investigatorMore trials in Thief River Falls
- Essentia Health Virginia Clinic · Virginia, MN 55792Bret Friday, MD · Study contact · 612-624-2620 · ccinfo@umn.eduBret Friday, MD · Principal investigatorMore trials in Virginia
- Sanford Worthington Medical Center · Worthington, MN 56187Jonathan Bleeker, MD · Study contact · jonathan.bleeker@sanfordhealth.orgJonathan Bleeker, MD · Principal investigatorMore trials in Worthington