<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/NCT04495751</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00067614</org_study_id>
    <secondary_id>WFBCCC 98320</secondary_id>
    <nct_id>NCT04495751</nct_id>
  </id_info>
  <brief_title>Muscadine Grape Extract to Improve Fatigue</brief_title>
  <official_title>FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      The purpose of this research is to see if muscadine grape extract improves fatigue in people&#xD;
      age 70 and above who have a history of treated cancer and report the symptom of fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS&#xD;
      Fatigue score from baseline to 12 weeks compared to placebo.&#xD;
&#xD;
      Secondary Objective(s)&#xD;
&#xD;
        -  To evaluate whether administration of muscadine grape extract supplementation (4 tablets&#xD;
           twice daily) causes changes in physical function (Pepper Assessment Tool for Disability&#xD;
           [PAT-D], Short Physical Performance Battery), physical fitness (6-minute walk), physical&#xD;
           activity (Minnesota Leisure Questionnaire), sedentary behavior (Sedentary Behavior&#xD;
           Questionnaire) from baseline to 12 weeks compared to placebo.&#xD;
&#xD;
        -  To compare changes in health related quality of life (PROMIS Global Health) at 12 weeks&#xD;
           in participants randomized to muscadine grape extract group vs. placebo.&#xD;
&#xD;
        -  To compare changes in the Fried frailty index at 12 weeks in participants randomized to&#xD;
           muscadine grape extract vs. placebo.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive muscadine grape extract orally (PO) twice daily (BID) for 12 weeks in&#xD;
      the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM II: Patients receive placebo PO BID for 12 weeks in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      After completion of study, patients are followed up for 30 days after the last dose of the&#xD;
      study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 20, 2021</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double blind study. Only the investigational pharmacists and the statisticians will be unblinded. The blind will be maintained until the study is complete.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>(PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pepper Assessment Tool for Disability (PAT-D) Questionnaire</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>Pepper Assessment Tool for Disability (PAT-D) will used to assess self-reported physical function. The (PAT-D) is a 19-item survey designed to assess domains of physical function in older adults which contains subscales on mobility, instrumental activities of daily living (IADLs), and basic activities of daily living (ADLs). Participant responses will best describe their ability to perform certain activities of daily living (On a scale of 1 to 5; 1 = usually did with no difficulty to 5 = unable to do. Minimum score of 19, max score of 95. A lower score indicates less difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>This questionnaire will assess self-reported physical activity with participants answering yes/no questions in regards to physical activities done in the past two weeks and the frequency of those activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>The Short Physical Performance Battery (SPPB) will be used to objectively assess lower extremity physical function. This validated measure comprises a short walk, repeated chair stands, and balance test. Each section is scored out of 4 points, so the highest total score for the SPPB is 12 points. Scores for all three tests will be combined. Lower scores on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walk Test</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>A 6-minute walk will be measured to assess physical fitness. The 6-minute walk is easy to administer in a clinical setting, accurately assesses submaximal exercise capacity, is an independent predictor of mortality and is correlated with peak V02 testing. The number of laps and distance walked on the final lap will be recorded. The total distance the participant walked will be entered onto the online database (1 lap = 30 meters distance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>The questionnaire will be used to measure sedentary behavior for time spent during a 24 hour period for weekday and weekend various activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Global Health Short Form (SF) - Quality of Life</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>The PROMIS Global Health Short Form (SF) is a 10-item questionnaire that will assess global quality of life including overall physical health, mental health, social health, pain, fatigue an overall perceived quality of life. Participants will respond to questions or statements with varied selections (excellent to poor; completely to not at all; never to always; and none to very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence - Pill Count</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adherence will be measured by pill count at study completion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fried Frailty Index</measure>
    <time_frame>At baseline and at 12 weeks</time_frame>
    <description>Frailty indexes will be assessed for differences between the two arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Muscadine Grape Extract Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Muscadine grape extract pill (12 week supply)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo provided (12 week supply)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Muscadine grape extract</intervention_name>
    <description>Four pills twice daily</description>
    <arm_group_label>Muscadine Grape Extract Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Four pills twice daily.</description>
    <arm_group_label>Placebo Arm</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>Muscadine Grape Extract Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Muscadine Grape Extract Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Participant Feedback</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Muscadine Grape Extract Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-reported history of cancer diagnosed &gt; 12 months prior to enrollment excluding&#xD;
             non-melanoma skin cancer with no evidence of disease at enrollment.&#xD;
&#xD;
          -  Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck,&#xD;
             colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric,&#xD;
             pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial&#xD;
             disease and in situ disease only is excluded)&#xD;
&#xD;
          -  Eligible hematologic malignancies include lymphoma any subtype any stage in remission,&#xD;
             multiple myeloma in remission, leukemia any subtype in remission.&#xD;
&#xD;
          -  Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy,&#xD;
             hormonal therapies, immunotherapy, biologic therapies.&#xD;
&#xD;
          -  All anti-cancer therapy completed &gt; 12 months prior to enrollment&#xD;
&#xD;
          -  Age 65 years and older&#xD;
&#xD;
          -  Presence of self-reported fatigue defined by a response of &quot;somewhat, quite a bit or&#xD;
             very much&quot; to the screening question &quot;During the past seven days, did you feel&#xD;
             fatigued: Not at all, a little bit, somewhat, quite a bit, very much?&quot;&#xD;
&#xD;
          -  Ability to walk without requiring assistance from another individual (use of cane or&#xD;
             walker acceptable)&#xD;
&#xD;
          -  Normal organ and marrow function as defined below:&#xD;
&#xD;
               -  leukocytes &gt;3,000/mcL&#xD;
&#xD;
               -  absolute neutrophil count &gt;1,500/mcL&#xD;
&#xD;
               -  platelets &gt;100,000/mcL&#xD;
&#xD;
               -  total bilirubin within normal institutional limits&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;2.5 X institutional upper limit of normal&#xD;
&#xD;
               -  creatinine clearance &gt;30 mL/min&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an IRB-approved informed consent&#xD;
             document (either directly or via a legally authorized representative).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active malignancy or on-going cancer treatment including oral anti-estrogen therapy,&#xD;
             immunotherapy, biologic therapy.&#xD;
&#xD;
          -  Men receiving androgen deprivation therapy&#xD;
&#xD;
          -  Use of Coumadin or Warfarin (other blood thinners are acceptable)&#xD;
&#xD;
          -  Symptomatic congestive heart failure&#xD;
&#xD;
          -  Lung disease requiring oxygen&#xD;
&#xD;
          -  End stage renal disease requiring dialysis&#xD;
&#xD;
          -  Inability to swallow capsules&#xD;
&#xD;
          -  Chronic nausea or diarrhea defined by a frequency of ≥ once per week&#xD;
&#xD;
          -  Hemoglobin &lt;10 g/dl&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social&#xD;
             situations that would limit compliance with study requirements.&#xD;
&#xD;
          -  Known untreated hypothyroidism&#xD;
&#xD;
          -  Allergy to muscadine grapes or muscadine grape preparations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi Klepin, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katherine Pleasant, BA</last_name>
    <phone>336-713-5045</phone>
    <email>kpleasan@wakehealth.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brittany M Davis, MDiv</last_name>
    <phone>336-716-3906</phone>
    <email>bmdavis@wakehealth.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wake Forest Baptist Comprehensive Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <email>sgolden@wakehealth.edu</email>
    </contact>
    <investigator>
      <last_name>Heidi Klepin, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Older</keyword>
  <keyword>Cancer</keyword>
  <keyword>Survivors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04495751
org study id: IRB00067614
secondary id: WFBCCC 98320
nct id: NCT04495751
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research is to see if muscadine grape extract improves fatigue in people
      age 70 and above who have a history of treated cancer and report the symptom of fatigue.
Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS
      Fatigue score from baseline to 12 weeks compared to placebo.

      Secondary Objective(s)

        -  To evaluate whether administration of muscadine grape extract supplementation (4 tablets
           twice daily) causes changes in physical function (Pepper Assessment Tool for Disability
           [PAT-D], Short Physical Performance Battery), physical fitness (6-minute walk), physical
           activity (Minnesota Leisure Questionnaire), sedentary behavior (Sedentary Behavior
           Questionnaire) from baseline to 12 weeks compared to placebo.

        -  To compare changes in health related quality of life (PROMIS Global Health) at 12 weeks
           in participants randomized to muscadine grape extract group vs. placebo.

        -  To compare changes in the Fried frailty index at 12 weeks in participants randomized to
           muscadine grape extract vs. placebo.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive muscadine grape extract orally (PO) twice daily (BID) for 12 weeks in
      the absence of disease progression or unacceptable toxicity.

      ARM II: Patients receive placebo PO BID for 12 weeks in the absence of disease progression or
      unacceptable toxicity.

      After completion of study, patients are followed up for 30 days after the last dose of the
      study drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: This is a double blind study. Only the investigational pharmacists and the statisticians will be unblinded. The blind will be maintained until the study is complete.
measure: Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
time frame: At baseline and at 12 weeks
description: (PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups.
measure: Pepper Assessment Tool for Disability (PAT-D) Questionnaire
time frame: At baseline and at 12 weeks
description: Pepper Assessment Tool for Disability (PAT-D) will used to assess self-reported physical function. The (PAT-D) is a 19-item survey designed to assess domains of physical function in older adults which contains subscales on mobility, instrumental activities of daily living (IADLs), and basic activities of daily living (ADLs). Participant responses will best describe their ability to perform certain activities of daily living (On a scale of 1 to 5; 1 = usually did with no difficulty to 5 = unable to do. Minimum score of 19, max score of 95. A lower score indicates less difficulty.
measure: Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
time frame: At baseline and at 12 weeks
description: This questionnaire will assess self-reported physical activity with participants answering yes/no questions in regards to physical activities done in the past two weeks and the frequency of those activities.
measure: Short Physical Performance Battery (SPPB)
time frame: At baseline and at 12 weeks
description: The Short Physical Performance Battery (SPPB) will be used to objectively assess lower extremity physical function. This validated measure comprises a short walk, repeated chair stands, and balance test. Each section is scored out of 4 points, so the highest total score for the SPPB is 12 points. Scores for all three tests will be combined. Lower scores on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
measure: 6-Minute Walk Test
time frame: At baseline and at 12 weeks
description: A 6-minute walk will be measured to assess physical fitness. The 6-minute walk is easy to administer in a clinical setting, accurately assesses submaximal exercise capacity, is an independent predictor of mortality and is correlated with peak V02 testing. The number of laps and distance walked on the final lap will be recorded. The total distance the participant walked will be entered onto the online database (1 lap = 30 meters distance).
measure: Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
time frame: At baseline and at 12 weeks
description: The questionnaire will be used to measure sedentary behavior for time spent during a 24 hour period for weekday and weekend various activities.
measure: PROMIS Global Health Short Form (SF) - Quality of Life
time frame: At baseline and at 12 weeks
description: The PROMIS Global Health Short Form (SF) is a 10-item questionnaire that will assess global quality of life including overall physical health, mental health, social health, pain, fatigue an overall perceived quality of life. Participants will respond to questions or statements with varied selections (excellent to poor; completely to not at all; never to always; and none to very severe).
measure: Adherence - Pill Count
time frame: 12 weeks
description: Adherence will be measured by pill count at study completion.
measure: Fried Frailty Index
time frame: At baseline and at 12 weeks
description: Frailty indexes will be assessed for differences between the two arms.
arm group label: Muscadine Grape Extract Arm
arm group type: Experimental
description: Muscadine grape extract pill (12 week supply)
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Placebo provided (12 week supply)
intervention type: Dietary Supplement
intervention name: Muscadine grape extract
description: Four pills twice daily
arm group label: Muscadine Grape Extract Arm
intervention type: Drug
intervention name: Placebo
description: Four pills twice daily.
arm group label: Placebo Arm
intervention type: Other
intervention name: Quality of Life Assessment
description: Ancillary studies
arm group label: Muscadine Grape Extract Arm
arm group label: Placebo Arm
intervention type: Other
intervention name: Questionnaires
description: Ancillary studies
arm group label: Muscadine Grape Extract Arm
arm group label: Placebo Arm
intervention type: Other
intervention name: Participant Feedback
description: Ancillary studies
arm group label: Muscadine Grape Extract Arm
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Heidi Klepin, MD, MS
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Katherine Pleasant, BA
phone: 336-713-5045
email: kpleasan@wakehealth.edu
last name: Brittany M Davis, MDiv
phone: 336-716-3906
email: bmdavis@wakehealth.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No