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

Primary Purpose

Estrogen Receptor-Positive Breast Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mushroom
Placebo Administration
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Estrogen Receptor-Positive Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative Fatigue ≥ 4/10 Currently 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) 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) 0, 1 or 2 White blood cell count (WBC) ≥ 3,000/mm^3 (obtained ≤ 30 days prior to randomization) Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to randomization) Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to randomization) Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization) Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 1.2 x ULN (obtained ≤ 30 days prior to randomization) Prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization) Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only Provide written informed consent Ability to complete questionnaires Willing to return to enrolling institution during the active monitoring phase of the study Exclusion Criteria: 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) Metastatic cancer diagnosis (history of nodal metastases is allowed) Chronic steroid use, unless on physiologic replacement doses Current use of any medical mushrooms On medications for diabetes History of symptomatic hypotension Taking CYP3A4, CYP2D6 or CYP2E1 substrates Taking CDK4/6 inhibitors or olaparib Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects: Pregnant persons Nursing persons Persons of childbearing potential who are unwilling to employ adequate contraception

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (Reishi mushroom extract, placebo)

Arm II (placebo, Reishi mushroom extract)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 31, 2023
Last Updated
October 18, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06028022
Brief Title
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Official Title
Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of 1,000 mg three times daily (TID) of Reishi mushroom extracts as therapy for cancer-related fatigue measured by uniscale measurement at the end of four weeks. SECONDARY OBJECTIVES: I. To evaluate the efficacy of Reishi mushroom extracts as therapy for cancer-related arthralgias at the end of four weeks and four weeks after cross-over as measured by the Brief Pain index (BPI)-adapted for AI associated arthralgias. II. To evaluate the effect of Reishi mushroom extracts on cancer-related quality of life (QOL), as measured by uniscale, at the end of four weeks and four weeks after cross-over. III. To evaluate the efficacy of Reishi mushroom extracts on mood, as assessed by the World Health Organization Five Well-Being Index (WHO-5) item well-being scale, at the end of four weeks and four weeks after cross-over. IV. To evaluate treatment toxicity between the two treatment arms, as measured by a patient symptom experience diary and weekly calls from the study team. V. To evaluate the interest, knowledge, and acceptance of integrative treatments for cancer-related symptoms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive Reishi mushroom extract orally (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. ARM II: 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. After completion of study treatment, patients are followed up at 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor-Positive Breast Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Reishi mushroom extract, placebo)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (placebo, Reishi mushroom extract)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mushroom
Other Intervention Name(s)
CULTIVATED MUSHROOM
Intervention Description
Given Reishi mushroom extract PO
Intervention Type
Drug
Intervention Name(s)
Placebo Administration
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in fatigue scores
Description
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 Outcome Measure Information:
Title
Change in quality of life
Description
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
Title
Change in arthralgias
Description
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
Title
Incidence of adverse events
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative Fatigue ≥ 4/10 Currently 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) 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) 0, 1 or 2 White blood cell count (WBC) ≥ 3,000/mm^3 (obtained ≤ 30 days prior to randomization) Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to randomization) Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to randomization) Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization) Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 1.2 x ULN (obtained ≤ 30 days prior to randomization) Prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization) Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only Provide written informed consent Ability to complete questionnaires Willing to return to enrolling institution during the active monitoring phase of the study Exclusion Criteria: 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) Metastatic cancer diagnosis (history of nodal metastases is allowed) Chronic steroid use, unless on physiologic replacement doses Current use of any medical mushrooms On medications for diabetes History of symptomatic hypotension Taking CYP3A4, CYP2D6 or CYP2E1 substrates Taking CDK4/6 inhibitors or olaparib Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects: Pregnant persons Nursing persons Persons of childbearing potential who are unwilling to employ adequate contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy D D'Andre, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Stacy D. D'Andre, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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