xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06028022</url>
    </required_header>
    <id_info>
      <org_study_id>MC221002</org_study_id>
      <secondary_id>NCI-2023-06578</secondary_id>
      <secondary_id>MC221002</secondary_id>
      <secondary_id>23-005266</secondary_id>
      <nct_id>NCT06028022</nct_id>
    </id_info>
    <brief_title>Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors</brief_title>
    <official_title>Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or&#xD;
        joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase&#xD;
        inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients&#xD;
        taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up&#xD;
        to 10 years), these symptoms can significantly impact quality of life and premature&#xD;
        discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal&#xD;
        mushrooms that have been used for hundreds of years, mainly in Asian countries, to help&#xD;
        enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom&#xD;
        extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but&#xD;
        have been shown to improve quality of life, muscular strength, pain, and flexibility.&#xD;
        Information from this study may help researchers determine the effect of Reishi mushroom&#xD;
        extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To evaluate the efficacy of 1,000 mg three times daily (TID) of Reishi mushroom extracts&#xD;
        as therapy for cancer-related fatigue measured by uniscale measurement at the end of four&#xD;
        weeks.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate the efficacy of Reishi mushroom extracts as therapy for cancer-related&#xD;
        arthralgias at the end of four weeks and four weeks after cross-over as measured by the Brief&#xD;
        Pain index (BPI)-adapted for AI associated arthralgias.&#xD;
  &#xD;
        II. To evaluate the effect of Reishi mushroom extracts on cancer-related quality of life&#xD;
        (QOL), as measured by uniscale, at the end of four weeks and four weeks after cross-over.&#xD;
  &#xD;
        III. To evaluate the efficacy of Reishi mushroom extracts on mood, as assessed by the World&#xD;
        Health Organization Five Well-Being Index (WHO-5) item well-being scale, at the end of four&#xD;
        weeks and four weeks after cross-over.&#xD;
  &#xD;
        IV. To evaluate treatment toxicity between the two treatment arms, as measured by a patient&#xD;
        symptom experience diary and weekly calls from the study team.&#xD;
  &#xD;
        V. To evaluate the interest, knowledge, and acceptance of integrative treatments for&#xD;
        cancer-related symptoms.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I: Patients receive Reishi mushroom extract orally (PO) TID on days 1-28 for weeks 1-4&#xD;
        and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or&#xD;
        unacceptable toxicity.&#xD;
  &#xD;
        ARM II: Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom&#xD;
        extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or&#xD;
        unacceptable toxicity.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up at 30 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in fatigue scores</measure>
      <time_frame>Baseline to end of four weeks</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>Baseline to the end of four weeks and four weeks after cross-over</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in arthralgias</measure>
      <time_frame>Baseline to the end of four weeks and four weeks after cross-over</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Up to 30 days follow-up</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Estrogen Receptor-Positive Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (Reishi mushroom extract, placebo)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (placebo, Reishi mushroom extract)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Mushroom</intervention_name>
      <description>Given Reishi mushroom extract PO</description>
      <arm_group_label>Arm I (Reishi mushroom extract, placebo)</arm_group_label>
      <arm_group_label>Arm II (placebo, Reishi mushroom extract)</arm_group_label>
      <other_name>CULTIVATED MUSHROOM</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Administration</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Arm I (Reishi mushroom extract, placebo)</arm_group_label>
      <arm_group_label>Arm II (placebo, Reishi mushroom extract)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality-of-Life Assessment</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (Reishi mushroom extract, placebo)</arm_group_label>
      <arm_group_label>Arm II (placebo, Reishi mushroom extract)</arm_group_label>
      <other_name>Quality of Life Assessment</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (Reishi mushroom extract, placebo)</arm_group_label>
      <arm_group_label>Arm II (placebo, Reishi mushroom extract)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative&#xD;
  &#xD;
            -  Fatigue ≥ 4/10&#xD;
  &#xD;
            -  Currently taking any aromatase inhibitor in the curative setting and planning to be on&#xD;
               such for at least 8 weeks after registration. (Patients on concurrent ovarian&#xD;
               suppression [such as with leuprolide acetate, goserelin] are allowed)&#xD;
  &#xD;
            -  Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated with&#xD;
               chemotherapy)&#xD;
  &#xD;
            -  On a stable dose of pain medications if pain medications are being regularly used.&#xD;
               (i.e., no change in dosage in the past 30 days)&#xD;
  &#xD;
            -  If on supplements, must be on stable dose with no plan to change; not on or planning&#xD;
               any acupuncture or other specific supportive modalities for fatigue or AI arthralgias&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2&#xD;
  &#xD;
            -  White blood cell count (WBC) ≥ 3,000/mm^3 (obtained ≤ 30 days prior to randomization)&#xD;
  &#xD;
            -  Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to randomization)&#xD;
  &#xD;
            -  Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to randomization)&#xD;
  &#xD;
            -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 30 days prior to&#xD;
               randomization)&#xD;
  &#xD;
            -  Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 1.2 x ULN (obtained ≤&#xD;
               30 days prior to randomization)&#xD;
  &#xD;
            -  Prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN&#xD;
               (obtained ≤ 30 days prior to randomization)&#xD;
  &#xD;
            -  Negative pregnancy test done ≤ 7 days prior to registration, for persons of&#xD;
               childbearing potential only&#xD;
  &#xD;
            -  Provide written informed consent&#xD;
  &#xD;
            -  Ability to complete questionnaires&#xD;
  &#xD;
            -  Willing to return to enrolling institution during the active monitoring phase of the&#xD;
               study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other known uncontrolled medical conditions causing fatigue such as untreated thyroid&#xD;
               disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune&#xD;
               disease, or active/untreated hepatitis&#xD;
  &#xD;
            -  Allergy to mushrooms&#xD;
  &#xD;
            -  On anticoagulation medication or aspirin or having a known bleeding disorder&#xD;
  &#xD;
            -  On any specific medication for fatigue (e.g., methylphenidate)&#xD;
  &#xD;
            -  Metastatic cancer diagnosis (history of nodal metastases is allowed)&#xD;
  &#xD;
            -  Chronic steroid use, unless on physiologic replacement doses&#xD;
  &#xD;
            -  Current use of any medical mushrooms&#xD;
  &#xD;
            -  On medications for diabetes&#xD;
  &#xD;
            -  History of symptomatic hypotension&#xD;
  &#xD;
            -  Taking CYP3A4, CYP2D6 or CYP2E1 substrates&#xD;
  &#xD;
            -  Taking CDK4/6 inhibitors or olaparib&#xD;
  &#xD;
            -  Any of the following because this study involves an agent that has unknown genotoxic,&#xD;
               mutagenic and teratogenic effects:&#xD;
  &#xD;
                 -  Pregnant persons&#xD;
  &#xD;
                 -  Nursing persons&#xD;
  &#xD;
                 -  Persons of childbearing potential who are unwilling to employ adequate&#xD;
                    contraception&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stacy D D'Andre, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic in Rochester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic in Rochester</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Stacy D. D'Andre, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Arthralgia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06028022
  org study id: MC221002
  secondary id: NCI-2023-06578
  secondary id: MC221002
  secondary id: 23-005266
  nct id: NCT06028022
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Change in fatigue scores
  time frame: Baseline to end of four weeks
  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.
  measure: Change in quality of life
  time frame: Baseline to the end of four weeks and four weeks after cross-over
  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.
  measure: Change in arthralgias
  time frame: Baseline to the end of four weeks and four weeks after cross-over
  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.
  measure: Incidence of adverse events
  time frame: Up to 30 days follow-up
  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.
  arm group label: Arm I (Reishi mushroom extract, placebo)
  arm group type: Experimental
  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 group label: Arm II (placebo, Reishi mushroom extract)
  arm group type: Experimental
  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: Mushroom
  description: Given Reishi mushroom extract PO
  arm group label: Arm I (Reishi mushroom extract, placebo)
  arm group label: Arm II (placebo, Reishi mushroom extract)
  other name: CULTIVATED MUSHROOM
  intervention type: Drug
  intervention name: Placebo Administration
  description: Given PO
  arm group label: Arm I (Reishi mushroom extract, placebo)
  arm group label: Arm II (placebo, Reishi mushroom extract)
  intervention type: Other
  intervention name: Quality-of-Life Assessment
  description: Ancillary studies
  arm group label: Arm I (Reishi mushroom extract, placebo)
  arm group label: Arm II (placebo, Reishi mushroom extract)
  other name: Quality of Life Assessment
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm I (Reishi mushroom extract, placebo)
  arm group label: Arm II (placebo, Reishi mushroom extract)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stacy D D'Andre, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic in Rochester
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Arthralgia