Health TrialsbyHealthPanel

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

ConditionEstrogen Receptor-Positive Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or active/untreated hepatitis

Allergy to mushrooms

On anticoagulation medication or aspirin or having a known bleeding disorder

On any specific medication for fatigue (e.g., methylphenidate)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Mushroom Extract

    Dietary supplement

    Given Reishi mushroom extract PO

  • Placebo Administration

    Drug

    Given PO

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm I (Reishi mushroom extract, placebo)Experimental treatment 4 interventions
Group B: Arm II (placebo, Reishi mushroom extract)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in fatigue scores

Based on a single item fatigue uniscale question. Will be compared between arms using a two-sided two-sample t-test assuming equal variances in each group.

Time frame
Baseline to end of four weeks

Secondary outcomes

1

Change in quality of life

Measured by the World Health Organization-Five Well-Being Index. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.

Time frame
Baseline to the end of four weeks and four weeks after cross-over
2

Change in arthralgias

Measured by the Brief Pain Inventory for Aromatase Inhibitor Induced Arthralgia. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.

Time frame
Baseline to the end of four weeks and four weeks after cross-over
3

Incidence of adverse events

Measured by the symptom experience diary. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach.

Time frame
Up to 30 days follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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