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Phase 2
Age: 18Years +
FEMALE
ID06028022

Reishi Mushroom Extract to Reduce Fatigue and JointMuscle Pain in Women With Estrogen Receptor-Positive Breast Cancer Taking Aromatase Inhibitors

Led by Mayo Clinic · Updated on 2026-06-16

80

Participants Needed

23

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Reishi mushroom extract on fatigue and joint or muscle pain in women with estrogen receptor-positive breast cancer who are taking aromatase inhibitors. These symptoms are common and can affect quality of life and continuation of aromatase inhibitor therapy, which may last up to 10 years. Reishi mushrooms have traditionally been used to support the immune system, reduce stress, improve sleep, and lessen fatigue, but their effect on treatment-related pain and fatigue has not been specifically studied in this group. Participants are randomly assigned to one of two groups in this phase II trial. One group receives 1,000 mg of Reishi mushroom extract orally three times daily for four weeks followed by a placebo for the next four weeks. The other group receives placebo first for four weeks and then the Reishi extract for four weeks. After completing the treatment periods, patients are followed for 30 days to monitor safety and outcomes. During the study, participants complete quality-of-life assessments, pain and fatigue questionnaires, and mood evaluations. Researchers track treatment side effects through symptom diaries and weekly phone calls. The main outcome is the change in fatigue levels at four weeks. Secondary outcomes include changes in jointmuscle pain, quality of life, mood, and any adverse effects during the 30-day follow-up. Participants are expected to attend scheduled visits and complete questionnaires throughout the trial.

CONDITIONS

Brief Title

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

Research Team

C

Clinical Trials Referral Office

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