<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/NCT04473378</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS3402</org_study_id>
    <nct_id>NCT04473378</nct_id>
  </id_info>
  <brief_title>Glucose Monitoring During Chemotherapy</brief_title>
  <official_title>Pilot Study of Glucose Monitoring to Determine Rates of Hyperglycemia During Chemotherapy for Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a research study to look at blood sugar changes during chemotherapy using a&#xD;
      continuous blood sugar monitoring device. The device uses patches that attach to the skin on&#xD;
      the back of the arm to measure blood sugar changes for the duration of the chemotherapy&#xD;
      course. Each patch lasts for about 2-weeks. During chemotherapy visits, new patches will be&#xD;
      placed and will be worn until the chemotherapy course is complete. Participants will be in&#xD;
      this study for 6 months. Approximately 50 patients will be enrolled in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational cohort study monitoring trends in glucose in patients&#xD;
      with early stage breast cancer treated with neoadjuvant or adjuvant chemotherapy. Patients&#xD;
      will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for the duration&#xD;
      of chemotherapy. The primary goal of this trial is to evaluate the prevalence of&#xD;
      hyperglycemia in patients with early-stage breast cancer during neoadjuvant/adjuvant&#xD;
      chemotherapy. Fifty patients will be enrolled. During each chemotherapy encounter, subjects&#xD;
      will have their glucose sensor scanned in order to download subjects' glucose data. If the&#xD;
      sensor has become no longer adherent to the participant's skin, participants will bring the&#xD;
      sensor with them to the chemotherapy infusion center to be scanned. During each chemotherapy&#xD;
      encounter, the Free Style Libre sensor will be replaced by the study team. Participants who&#xD;
      receive chemotherapy every three weeks will be asked to come in 10-14 days after their&#xD;
      chemotherapy infusion to replace the sensor. The sensors will be worn through completion of&#xD;
      chemotherapy (the duration will vary based on the individual's chemotherapy regimen).&#xD;
      Patients will have fructosamine, a glucose biomarker, and serum creatinine testing at&#xD;
      baseline and every 3 weeks (weeks 3, 6, 9, 12, 15, 18, 21, 24) until week 24 (note: week 15,&#xD;
      18, and 21 are optional). Patients will have additional glucose biomarker testing (hemoglobin&#xD;
      a1c, glucose, and insulin [fasting preferred]) at baseline, week 12 and week 24. Patients&#xD;
      will also complete questionnaires assessing for symptoms of chemotherapy induced peripheral&#xD;
      neuropathy, quality of life, and fatigue at baseline, week 12 and week 24. Visits will be&#xD;
      conducted within the below specified windows forbidding unexpected circumstances such as&#xD;
      missed appointments or loss to follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 31, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of hyperglycemia</measure>
    <time_frame>24 weeks</time_frame>
    <description>assess the prevalence of HG, defined as the number of participants who have ≥1 glucose value of ≥140 mg/dL at any point during chemotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of impaired glucose tolerance at baseline in nondiabetic patients.</measure>
    <time_frame>Baseline</time_frame>
    <description>Prevalence of glucose intolerance will be defined as a hemoglobin a1c &gt;5.7% at baseline in nondiabetic patients The American Diabetes Association classifies individuals with a hemoglobin A1c level of 5.7-6.4% as having an increased risk of DM.The American Diabetes Association classified individuals with a hemoglobin A1c level of 6.5% or higher on two separate occasions as having a diagnosis of DM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS)-29</measure>
    <time_frame>Baseline, week 12, and week 24</time_frame>
    <description>The PROMIS-29 consists of 29 questions to measure global quality of life, including four questions from each of the following domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, satisfaction with participation in social roles, ability to participate in social roles and activities; it includes a single pain intensity item.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>FreeStyle Libre sensor cohort</arm_group_label>
    <description>Patients with early stage breast cancer will have their blood glucose levels monitored by the Freestyle libre pro sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FreeStyle Libre Pro</intervention_name>
    <description>The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course.</description>
    <arm_group_label>FreeStyle Libre sensor cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with early stage breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  History of stage I-III breast cancer&#xD;
&#xD;
          -  Patient scheduled to receive adjuvant or neoadjuvant chemotherapy&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with insulin&#xD;
&#xD;
          -  Current treatment with non-topical steroids, with the exception of steroid treatment&#xD;
             as a supportive chemotherapy medication&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Accordino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herbert Irving Pavilion</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Melissa K Accordino</investigator_full_name>
    <investigator_title>Assistant professor of medicine at CUMC</investigator_title>
  </responsible_party>
  <keyword>Freestyle Libre Pro</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04473378
org study id: AAAS3402
nct id: NCT04473378
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a research study to look at blood sugar changes during chemotherapy using a
      continuous blood sugar monitoring device. The device uses patches that attach to the skin on
      the back of the arm to measure blood sugar changes for the duration of the chemotherapy
      course. Each patch lasts for about 2-weeks. During chemotherapy visits, new patches will be
      placed and will be worn until the chemotherapy course is complete. Participants will be in
      this study for 6 months. Approximately 50 patients will be enrolled in this study.
This is a prospective observational cohort study monitoring trends in glucose in patients
      with early stage breast cancer treated with neoadjuvant or adjuvant chemotherapy. Patients
      will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for the duration
      of chemotherapy. The primary goal of this trial is to evaluate the prevalence of
      hyperglycemia in patients with early-stage breast cancer during neoadjuvant/adjuvant
      chemotherapy. Fifty patients will be enrolled. During each chemotherapy encounter, subjects
      will have their glucose sensor scanned in order to download subjects' glucose data. If the
      sensor has become no longer adherent to the participant's skin, participants will bring the
      sensor with them to the chemotherapy infusion center to be scanned. During each chemotherapy
      encounter, the Free Style Libre sensor will be replaced by the study team. Participants who
      receive chemotherapy every three weeks will be asked to come in 10-14 days after their
      chemotherapy infusion to replace the sensor. The sensors will be worn through completion of
      chemotherapy (the duration will vary based on the individual's chemotherapy regimen).
      Patients will have fructosamine, a glucose biomarker, and serum creatinine testing at
      baseline and every 3 weeks (weeks 3, 6, 9, 12, 15, 18, 21, 24) until week 24 (note: week 15,
      18, and 21 are optional). Patients will have additional glucose biomarker testing (hemoglobin
      a1c, glucose, and insulin [fasting preferred]) at baseline, week 12 and week 24. Patients
      will also complete questionnaires assessing for symptoms of chemotherapy induced peripheral
      neuropathy, quality of life, and fatigue at baseline, week 12 and week 24. Visits will be
      conducted within the below specified windows forbidding unexpected circumstances such as
      missed appointments or loss to follow-up.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of hyperglycemia
time frame: 24 weeks
description: assess the prevalence of HG, defined as the number of participants who have ≥1 glucose value of ≥140 mg/dL at any point during chemotherapy
measure: Prevalence of impaired glucose tolerance at baseline in nondiabetic patients.
time frame: Baseline
description: Prevalence of glucose intolerance will be defined as a hemoglobin a1c >5.7% at baseline in nondiabetic patients The American Diabetes Association classifies individuals with a hemoglobin A1c level of 5.7-6.4% as having an increased risk of DM.The American Diabetes Association classified individuals with a hemoglobin A1c level of 6.5% or higher on two separate occasions as having a diagnosis of DM.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
time frame: Baseline, week 12, and week 24
description: The PROMIS-29 consists of 29 questions to measure global quality of life, including four questions from each of the following domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, satisfaction with participation in social roles, ability to participate in social roles and activities; it includes a single pain intensity item.
arm group label: FreeStyle Libre sensor cohort
description: Patients with early stage breast cancer will have their blood glucose levels monitored by the Freestyle libre pro sensor.
intervention type: Device
intervention name: FreeStyle Libre Pro
description: The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course.
arm group label: FreeStyle Libre sensor cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa Accordino, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Melissa K Accordino
investigator title: Assistant professor of medicine at CUMC
mesh term: Breast Neoplasms
mesh term: Hyperglycemia
sharing ipd: Undecided