Estrogen Receptor-Positive Breast CarcinomaPhase 2NCT06028022
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
A Phase 2 study testing Mushroom Extract, Quality-of-Life Assessment and Questionnaire Administration in people with Estrogen Receptor-Positive Breast Carcinoma, run by Mayo Clinic at 23 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor-Positive Breast Carcinoma
- What is being tested?
- Mushroom Extract, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 23 sitesUnited States
- Study dates
- 18 Oct 2023to 15 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 22 recruiting
- Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Mina Hanna, MD
- Recruiting
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425
Bret E. Friday, M.D., 612-624-2620, ccinfo@umn.edu
Bret E. Friday, M.D.
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Jarrett Failing, MD, 612-624-2620, ccinfo@umn.edu
Jarrett Failing, MD
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Deer River Clinic
Deer River, Minnesota, 56636
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Bret E. Friday, MD, 218-786-3625, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Ely Clinic
Ely, Minnesota, 55731
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Fosston
Fosston, Minnesota, 56542
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
Aparna Basu, MD, 218-362-6230, marella.warner@fairview.org
Aparna Basu, MD
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Fairview Range Medical Center
Hibbing, Minnesota, 55746
Aparna Basu, MD, 218-362-6230, marella.warner@fairview.org
Aparna Basu, MD
- Recruiting
Essentia Health International Falls Clinic
International Falls, Minnesota, 56649
Bret E. Friday, M.D., 612-624-2620, ccinfo@umn.edu
Bret E. Friday, M.D.
- Recruiting
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Stephen D. Thome, MD
- Completed
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
- Recruiting
Essentia Health Moose Lake
Moose Lake, Minnesota, 55767
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Essentia Health Park Rapids
Park Rapids, Minnesota, 56470
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Fairview Northland Medical Center
Princeton, Minnesota, 55731
Aparna Basu, MD, 218-362-6230, marella.warner@fairview.org
Aparna Basu, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Stacy D. D'Andre, M.D.
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Bret E. Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret E. Friday, MD
- Recruiting
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Amit Panwalkar, MD, 612-624-2620, ccinfo@umn.edu
Amit Panwalkar, MD
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Sanford Worthington Medical Center
Worthington, Minnesota, 56187
Jonathan Bleeker, MD, jonathan.bleeker@sanfordhealth.org
Jonathan Bleeker, MD
About this study
Official title: Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Being tested
- Mushroom Extract, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom ExtractDietary supplement
Also called Agaricus bisporus Extract, Cultivated Mushroom
Given Reishi mushroom extract PO
Placebo AdministrationDrug
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Reishi mushroom extract, placebo) | Experimental | 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. Receives: Dietary Supplement: Mushroom Extract; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (placebo, Reishi mushroom extract) | Experimental | 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. Receives: Dietary Supplement: Mushroom Extract; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue scores
Based on a single item fatigue uniscale question. Will be compared between arms using a two-sided two-sample t-test assuming equal variances in each group.
Measured: Baseline to end of four weeks
Secondary outcomes (3)
Change in quality of life
Measured by the World Health Organization-Five Well-Being Index. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.
Measured: Baseline to the end of four weeks and four weeks after cross-over
Change in arthralgias
Measured by the Brief Pain Inventory for Aromatase Inhibitor Induced Arthralgia. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.
Measured: Baseline to the end of four weeks and four weeks after cross-over
Incidence of adverse events
Measured by the symptom experience diary. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.
Measured: Up to 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start18 Oct 2023
- Primary completion15 May 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor-Positive Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy D. D'Andre, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028022
- Sponsor's protocol ID
- MC221002
- Other IDs
- NCI-2023-06578, MC221002, 23-005266, MNCCTN032
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No