NCT06028022 Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
| NCT ID | NCT06028022 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Estrogen Receptor-Positive Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2026-10-16 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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)