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Reishi Mushroom Extract for Breast Cancer-Related Fatigue and Joint Pain

Phase 2

Recruiting

Led By Stacy D. D'Andre, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Must not have

Current use of any medical mushrooms

On medications for diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of four weeks

Summary

This trial tests if Reishi mushroom extract can reduce fatigue and joint/muscle pain in breast cancer patients taking aromatase inhibitors, which can cause long-term symptoms. Reishi mushrooms may help reduce stress, improve sleep, and lessen fatigue.

Who is the study for?

This trial is for adults over 18 with breast cancer who are experiencing fatigue and joint/muscle pain while on aromatase inhibitors. They should have finished chemotherapy at least 90 days ago, have a stable blood count, not be pregnant or nursing, and willing to use contraception if of childbearing potential. Exclusions include metastatic cancer diagnosis, chronic steroid use (except replacement doses), mushroom allergies, uncontrolled conditions causing fatigue, certain medication users including anticoagulants and specific enzyme substrates.

What is being tested?

The study examines the effectiveness of Reishi mushroom extract in reducing fatigue and joint/muscle pain in patients taking aromatase inhibitors for breast cancer treatment. Participants will either receive the mushroom extract or a placebo while their quality of life is assessed through questionnaires.

What are the potential side effects?

While side effects specific to Reishi mushroom extract aren't detailed here, common reactions may include digestive issues like nausea or diarrhea, skin rash or liver toxicity. As it's a natural supplement being tested against a placebo without known adverse effects from this context.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I often feel tired, rating my fatigue at least 4 out of 10.

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I have had breast cancer that was estrogen receptor positive and may or may not have been HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using medical mushrooms.

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I am taking medication for diabetes.

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I have had episodes of feeling faint or lightheaded due to low blood pressure.

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I am on blood thinners or have a bleeding disorder.

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I am on low-dose steroids for hormone replacement, not for treatment.

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I am currently taking CDK4/6 inhibitors or olaparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of four weeks and four weeks after cross-over

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the end of four weeks and four weeks after cross-over

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of four weeks and four weeks after cross-over for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fatigue scores

Secondary study objectives

Change in arthralgias

Change in quality of life

Incidence of adverse events

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (placebo, Reishi mushroom extract)Experimental Treatment4 Interventions

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.

Group II: Arm I (Reishi mushroom extract, placebo)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mushroom Extract

2012

N/A

~80

Placebo Administration

2018

Completed Phase 3

~2530