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Can a mushroom ease breast cancer treatment side effects?

NCT ID NCT06028022

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether Reishi mushroom extract can reduce fatigue and joint pain in breast cancer patients taking aromatase inhibitors. About 80 women with moderate to severe fatigue will receive either the mushroom extract or a placebo for 8 weeks. The goal is to see if this natural supplement improves quality of life and helps patients stick with their cancer therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Reishi mushroom extract
What this could lead to
If it works, this could offer a natural option to ease fatigue and joint pain, helping patients stay on their cancer treatment longer.
What could go wrong
This is a small, early-phase trial. The extract may not work better than placebo, and side effects or interactions with cancer drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

estrogen-receptor positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen receptor-positive breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Essentia Health Baxter Clinic

    RECRUITING

    Baxter, Minnesota, 56425, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Essentia Health Deer River Clinic

    RECRUITING

    Deer River, Minnesota, 56636, United States

    Contact Email: •••••@•••••

  • Essentia Health Ely Clinic

    RECRUITING

    Ely, Minnesota, 55731, United States

    Contact Email: •••••@•••••

  • Essentia Health Fosston

    RECRUITING

    Fosston, Minnesota, 56542, United States

    Contact Email: •••••@•••••

  • Essentia Health Hibbing Clinic

    RECRUITING

    Hibbing, Minnesota, 55746, United States

    Contact Email: •••••@•••••

  • Essentia Health International Falls Clinic

    RECRUITING

    International Falls, Minnesota, 56649, United States

    Contact Email: •••••@•••••

  • Essentia Health Moose Lake

    RECRUITING

    Moose Lake, Minnesota, 55767, United States

    Contact Email: •••••@•••••

  • Essentia Health Park Rapids

    RECRUITING

    Park Rapids, Minnesota, 56470, United States

    Contact Email: •••••@•••••

  • Essentia Health Saint Joseph's Medical Center

    RECRUITING

    Brainerd, Minnesota, 56401, United States

    Contact Email: •••••@•••••

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    RECRUITING

    Detroit Lakes, Minnesota, 56501, United States

    Contact Email: •••••@•••••

  • Essentia Health Sandstone

    RECRUITING

    Sandstone, Minnesota, 55072, United States

    Contact Email: •••••@•••••

  • Essentia Health Virginia Clinic

    RECRUITING

    Virginia, Minnesota, 55792, United States

    Contact Email: •••••@•••••

  • Fairview Grand Itasca Clinic & Hospital

    RECRUITING

    Grand Rapids, Minnesota, 55744, United States

  • Fairview Northland Medical Center

    RECRUITING

    Princeton, Minnesota, 55731, United States

  • Fairview Range Medical Center

    RECRUITING

    Hibbing, Minnesota, 55746, United States

  • MMCORC CentraCare Monticello Cancer Center

    COMPLETED

    Monticello, Minnesota, 55362, United States

  • Mayo Clinic Health System in Albert Lea

    RECRUITING

    Albert Lea, Minnesota, 56007, United States

    Contact Email: •••••@•••••

  • Mayo Clinic Health Systems-Mankato

    RECRUITING

    Mankato, Minnesota, 56001, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Sanford Joe Lueken Cancer Center

    RECRUITING

    Bemidji, Minnesota, 56601, United States

    Contact Email: •••••@•••••

  • Sanford Thief River Falls Medical Center

    RECRUITING

    Thief River Falls, Minnesota, 56701, United States

    Contact Email: •••••@•••••

  • Sanford Worthington Medical Center

    RECRUITING

    Worthington, Minnesota, 56187, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.