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NCT06028022 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Estrogen Receptor-Positive Breast Carcinoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
20
Study locations

NCT06028022 is a Phase 2 study of Estrogen Receptor-Positive Breast Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 80 participants, above the 64-participant average among 5 other Estrogen Receptor-Positive Breast Carcinoma trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 1 state.

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The verdict

NCT06028022, a Phase 2 study of Estrogen Receptor-Positive Breast Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
20
Study locations

Study 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). 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.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • DRUG Placebo Administration
  • DIETARY_SUPPLEMENT Mushroom Extract

Study Locations (20)

Minnesota

  • Mayo Clinic Health System in Albert Lea - Albert Lea
  • Essentia Health Baxter Clinic - Baxter
  • Sanford Joe Lueken Cancer Center - Bemidji
  • Essentia Health Saint Joseph's Medical Center - Brainerd
  • Essentia Health Deer River Clinic - Deer River
  • Essentia Health Saint Mary's - Detroit Lakes Clinic - Detroit Lakes
  • Essentia Health Cancer Center - Duluth
  • Essentia Health Ely Clinic - Ely
  • Essentia Health Fosston - Fosston
  • Fairview Grand Itasca Clinic & Hospital - Grand Rapids
  • Essentia Health Hibbing Clinic - Hibbing
  • Fairview Range Medical Center - Hibbing
  • Essentia Health International Falls Clinic - International Falls
  • Mayo Clinic Health Systems-Mankato - Mankato
  • MMCORC CentraCare Monticello Cancer Center - Monticello
  • Essentia Health Moose Lake - Moose Lake
  • Essentia Health Park Rapids - Park Rapids
  • Fairview Northland Medical Center - Princeton
  • Mayo Clinic in Rochester - Rochester
  • Essentia Health Sandstone - Sandstone

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2023-10-18
Est. Completion 2026-10-16
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT06028022

The ClinicalTrials.gov registry entry for NCT06028022 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 64-participant average among 5 other Estrogen Receptor-Positive Breast Carcinoma trials with a reported enrollment target (25% higher). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Estrogen Receptor-Positive Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.

NCT06028022 reports 20 study locations spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT06028022 about?

NCT06028022 is a clinical study titled "Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors". 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)...

What is the current status of trial NCT06028022?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2023-10-18. Estimated completion is 2026-10-16.

What conditions does trial NCT06028022 study?

This clinical trial studies the following conditions: Estrogen Receptor-Positive Breast Carcinoma.

What interventions are being tested in trial NCT06028022?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Mushroom Extract (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06028022?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06028022 being conducted?

This trial has 20 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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