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

Phase 2

Recruiting

Led By Stacy D D'Andre, M.D.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of four weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fatigue scores

Secondary outcome measures

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

Placebo Administration

2018

Completed Phase 3

~2540

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,215 Previous Clinical Trials

3,767,163 Total Patients Enrolled

83 Trials studying Breast Cancer

13,810 Patients Enrolled for Breast Cancer

Stacy D D'Andre, M.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential hazards associated with taking Mushroom as a treatment?

"As the trial is in Phase 2, there is evidence supporting Mushroom's safety but no data backing its efficacy. For this reason, our team at Power rated it a 2 on the 1 to 3 scale."

Answered by AI

Is there an ongoing call for participants in this research effort?

"At present, clinicaltrials.gov states that this research trial is not accepting any more patients. Initially posted on October 1st 2023 and last edited on August 31st 2023, the study has ceased recruitment for now; however, there are over two thousand four hundred other trials actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors

2023. "Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028022.