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/NCT05984888</url>
    </required_header>
    <id_info>
      <org_study_id>2023C0053</org_study_id>
      <nct_id>NCT05984888</nct_id>
    </id_info>
    <brief_title>Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer</brief_title>
    <acronym>MIND-BC</acronym>
    <official_title>Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer&#xD;
        treatments are an important contributor to dramatic improvements in the long-term survival of&#xD;
        women with BC. However, cancer treatment can lead to cognitive impairment and declines in&#xD;
        quality of life in women with BC. Many cancer survivors experience memory and brain function&#xD;
        decline following chemotherapy which can last for years. A newer diet pattern,&#xD;
        Mediterranean-DASH [Dietary Approaches to Stop Hypertension] Intervention for&#xD;
        Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND&#xD;
        diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids&#xD;
        (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy&#xD;
        foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which&#xD;
        may help alleviate negative cognitive outcomes from cancer treatments. This randomized&#xD;
        controlled trial aims to investigate the effect of the MIND diet on cognitive functions in&#xD;
        women with invasive BC starting systemic therapies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)</measure>
      <time_frame>One day</time_frame>
      <description>Assess cognition remotely through a Zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. The HVLT is broken down into three trials of free-recall from a 12-item list of words, followed by a period of time then a fourth recall trial. Finally, the test ends with a recognition task. For all trials, the maximum score is 12 with higher scores indicating better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Remote assessment of cognition using the WAIS-IV Digit Span</measure>
      <time_frame>One day</time_frame>
      <description>Assess cognition remotely through a Zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. The WAIS-IV Digit Span is comprised of three individual tests: Digit Span Forward, Digit Span Backward, and Digit Span Sequence. A total potential score of 48 with higher scores indicating better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Remote assessment of cognition using the Oral Trail Making Test</measure>
      <time_frame>One day</time_frame>
      <description>Assess cognition remotely through a Zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. The OTMT is divided into part A and part B. The part A asks participants to count from 1-25, while part B asks participants to alternate between letters and numbers. The less amount of time required to complete the task equates to better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Remote assessment of cognition using the COWA Test</measure>
      <time_frame>One day</time_frame>
      <description>Assess cognition remotely through a Zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. The COWAT has two components, the first asks the participants to say as many words as possible that begin with a given letter (F, A, or S) within the one-minute time frame. The second trial asks the same task but instead of letters, the participant is asked to produce as many animals as possible within the provided time frame. More words produced are indicative of better cognitive function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of presence of CRCI symptoms (Neuro-Qol)</measure>
      <time_frame>One day</time_frame>
      <description>Assess the presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function. Higher scores indicate better cognitive functioning with a range from 8 - 40 for the raw score and a T-score range from 17.3 - 64.2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of presence of CRCI symptoms (FACT-Cog)</measure>
      <time_frame>One day</time_frame>
      <description>Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog), a self-report measurement of cognitive function. Higher scores indicate better cognition with a range from 0 - 80.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of Diet Quality Measures</measure>
      <time_frame>One day</time_frame>
      <description>Assess diet quality measures from an electronic food frequency questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>MIND-BC Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>General Health Curriculum (GHC) Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sessions of non-diet related health topic education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MIND Diet Intervention Group</intervention_name>
      <description>Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.</description>
      <arm_group_label>MIND-BC Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>General Health Curriculum (GHC) Group</intervention_name>
      <description>Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.</description>
      <arm_group_label>General Health Curriculum (GHC) Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stage II-IV hormone receptor+, breast cancer diagnosis&#xD;
  &#xD;
            -  Post-menopausal (defined as at least 1-year post menses, on ovarian suppression&#xD;
               medication, or s/p oophorectomy)&#xD;
  &#xD;
            -  Within +/- 4 weeks of starting initial systemic therapies (e.g. chemotherapy, targeted&#xD;
               therapies, endocrine therapy)&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of dementia, stroke, traumatic brain injury, brain metastasis or other&#xD;
               conditions that could lead to cognitive impairment&#xD;
  &#xD;
            -  MIND diet score &gt;8&#xD;
  &#xD;
            -  Unwilling/unable to eat &gt;2 types of MIND food&#xD;
  &#xD;
            -  Receiving insulin therapy for diabetes&#xD;
  &#xD;
            -  Diagnosis of triple negative breast cancer&#xD;
  &#xD;
            -  Unable to give informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tonya S Orchard, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tonya S Orchard, PhD</last_name>
      <phone>614-292-7241</phone>
      <email>orchard.6@osu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kellie R Weinhold, MS</last_name>
      <email>weinhold.8@osu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Ohio State University</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tonya S Orchard, PhD</last_name>
        <phone>614-292-7241</phone>
        <email>orchard.6@osu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Kellie R Weinhold, MS</last_name>
        <email>weinhold.8@osu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Tonya S Orchard, PhD</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>May 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Tonya Orchard</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05984888
  org study id: 2023C0053
  nct id: NCT05984888
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer
        treatments are an important contributor to dramatic improvements in the long-term survival of
        women with BC. However, cancer treatment can lead to cognitive impairment and declines in
        quality of life in women with BC. Many cancer survivors experience memory and brain function
        decline following chemotherapy which can last for years. A newer diet pattern,
        Mediterranean-DASH [Dietary Approaches to Stop Hypertension] Intervention for
        Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND
        diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids
        (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy
        foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which
        may help alleviate negative cognitive outcomes from cancer treatments. This randomized
        controlled trial aims to investigate the effect of the MIND diet on cognitive functions in
        women with invasive BC starting systemic therapies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
  time frame: One day
  description: Assess cognition remotely through a Zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. The HVLT is broken down into three trials of free-recall from a 12-item list of words, followed by a period of time then a fourth recall trial. Finally, the test ends with a recognition task. For all trials, the maximum score is 12 with higher scores indicating better cognition.
  measure: Remote assessment of cognition using the WAIS-IV Digit Span
  time frame: One day
  description: Assess cognition remotely through a Zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. The WAIS-IV Digit Span is comprised of three individual tests: Digit Span Forward, Digit Span Backward, and Digit Span Sequence. A total potential score of 48 with higher scores indicating better cognition.
  measure: Remote assessment of cognition using the Oral Trail Making Test
  time frame: One day
  description: Assess cognition remotely through a Zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. The OTMT is divided into part A and part B. The part A asks participants to count from 1-25, while part B asks participants to alternate between letters and numbers. The less amount of time required to complete the task equates to better cognition.
  measure: Remote assessment of cognition using the COWA Test
  time frame: One day
  description: Assess cognition remotely through a Zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. The COWAT has two components, the first asks the participants to say as many words as possible that begin with a given letter (F, A, or S) within the one-minute time frame. The second trial asks the same task but instead of letters, the participant is asked to produce as many animals as possible within the provided time frame. More words produced are indicative of better cognitive function.
  measure: Assessment of presence of CRCI symptoms (Neuro-Qol)
  time frame: One day
  description: Assess the presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function. Higher scores indicate better cognitive functioning with a range from 8 - 40 for the raw score and a T-score range from 17.3 - 64.2.
  measure: Assessment of presence of CRCI symptoms (FACT-Cog)
  time frame: One day
  description: Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog), a self-report measurement of cognitive function. Higher scores indicate better cognition with a range from 0 - 80.
  measure: Assessment of Diet Quality Measures
  time frame: One day
  description: Assess diet quality measures from an electronic food frequency questionnaire.
  arm group label: MIND-BC Intervention Group
  arm group type: Experimental
  description: Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.
  arm group label: General Health Curriculum (GHC) Control
  arm group type: Active Comparator
  description: Sessions of non-diet related health topic education.
  intervention type: Behavioral
  intervention name: MIND Diet Intervention Group
  description: Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.
  arm group label: MIND-BC Intervention Group
  intervention type: Behavioral
  intervention name: General Health Curriculum (GHC) Group
  description: Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.
  arm group label: General Health Curriculum (GHC) Control
  criteria: 
  gender: Female
  minimum age: 45 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Tonya S Orchard, PhD
  role: Principal Investigator
  affiliation: Ohio State University
  last name: Tonya S Orchard, PhD
  phone: 614-292-7241
  email: orchard.6@osu.edu
  last name: Kellie R Weinhold, MS
  email: weinhold.8@osu.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University
  investigator full name: Tonya Orchard
  investigator title: Associate Professor
  mesh term: Breast Neoplasms
  sharing ipd: No