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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 9 months later Aug 15, 2027 → May 15, 2029
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Record History

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  1. Primary completion pushed from Aug 15, 2027 to May 15, 2029 Show 4 more changesShow less
    • Study completion pushed from Sep 15, 2027 to Jun 15, 2029
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 4 of 23 sites
  2. Primary completion pushed from Oct 16, 2026 to Aug 15, 2027
    • Study completion pushed from Oct 16, 2026 to Sep 15, 2027
    v15
  3. Site details revised at 1 of 23 sitesv14
  4. Site details revised at 1 of 23 sitesv13
  5. Eligibility criteria expanded, about 44 wordsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Oct 16, 2025 to Oct 16, 2026
    • Study sites: 20 to 23
    v11
  2. Study sites: 18 to 20
    • Eligibility criteria shortened, about 1 word
    v10
  3. Study sites: 3 to 18v9
  4. Eligibility criteria expanded, about 24 wordsv8
  5. Site details revised at 3 of 3 sitesv7
  6. Primary and study completion dates: Oct 2025 to Oct 16, 2025
    • Interventions: Mushroom (Dietary Supplement), Placebo Administration (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other) to Mushroom Extract (Dietary Supplement), Placebo Administration (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration…
    v6
  7. Study sites: 1 to 3v5
  8. Re-verified, no change to tracked fieldsv4
  9. Eligibility criteria expanded, about 30 wordsv3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Oct 18, 2023
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
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Breast Cancer
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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.
Trial Details
NCT Number NCT06028022
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Estrogen Receptor-Positive Breast Carcinoma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov