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

Conditions

• Estrogen Receptor-Positive Breast Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mushroom Extract — DIETARY_SUPPLEMENT
  Given Reishi mushroom extract PO
• Placebo Administration — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Oct 18, 2023

Status verified

Dec 2025

Primary completion

Oct 16, 2026

Completion

Oct 16, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (Reishi mushroom extract, placebo)
  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.
• Experimental: Arm II (placebo, Reishi mushroom extract)
  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.

Primary Outcome Measure

Change in fatigue scores [ Time Frame: Baseline to end of four weeks ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]

Locations (23)

Find similar trials in Albert Lea, MN

Related Studies

• Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Tucson, Arizona
• Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
  PHASE2 · Recruiting · City of Hope Medical Center · Duarte, California
• Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy
  Recruiting · Mayo Clinic · Jacksonville, Florida
• Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
  PHASE2 · Recruiting · Mayo Clinic · Scottsdale, Arizona