<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/NCT04499950</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00223131</org_study_id>
    <nct_id>NCT04499950</nct_id>
  </id_info>
  <brief_title>Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study</brief_title>
  <acronym>A-NEW</acronym>
  <official_title>A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Institute for Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Breast Cancer Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopkins-WellSpan Cancer Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm phase II study designed to determine the effects of pharmacotherapy and&#xD;
      a remote behavioral weight loss intervention on weight loss in breast cancer survivors who&#xD;
      are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut&#xD;
      microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate the extent to which implementation of a chronic weight loss&#xD;
      medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss.&#xD;
      All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have&#xD;
      a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral&#xD;
      coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9,&#xD;
      those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while&#xD;
      those who lose &lt;5%, designated slow responders, will continue BWL and initiate Contrave&#xD;
      (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug&#xD;
      Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5%&#xD;
      weight loss is not achieved at month 6. During month 3, all participants continue to have&#xD;
      weekly calls with the behavioral coach and will be asked about symptoms, which may be related&#xD;
      to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation.&#xD;
      In addition to total weight loss, the investigators will evaluate biomarkers associated with&#xD;
      obesity, microbiome and cardiometabolic factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 8, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with 5 percent weight loss (in SLOW-BWL)</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF1 levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting glucose levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting lipids levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>6 Months</time_frame>
    <description>To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting insulin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leptin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Microbiome composition among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NCI quick food scan comparison among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minutes of Moderate to Vigorous Physical Activity (MVPA)</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of daily steps</measure>
    <time_frame>Baseline, 2 months and 6 Months</time_frame>
    <description>To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients with 5% weight loss (in FAST-BWL)</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with AA genotype and 5% weight loss</measure>
    <time_frame>6 months</time_frame>
    <description>To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve ≥5% weight loss and improvement in biomarkers at 6 months compared to the women who do not.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with AA genotype and Contrave</measure>
    <time_frame>6 months</time_frame>
    <description>To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Overweight or Obesity</condition>
  <arm_group>
    <arm_group_label>SLOW-BWL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose &lt;5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAST-BWL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Contrave</intervention_name>
    <description>Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.</description>
    <arm_group_label>SLOW-BWL</arm_group_label>
    <other_name>Naltrexone/Bupropion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Weight Loss</intervention_name>
    <description>6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.</description>
    <arm_group_label>FAST-BWL</arm_group_label>
    <arm_group_label>SLOW-BWL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, at least 3 months after completion of local therapy (e.g. surgery, radiation),&#xD;
             and if applicable, adjuvant chemotherapy&#xD;
&#xD;
          -  Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ&#xD;
             (DCIS) or stage I-III invasive carcinoma of the breast&#xD;
&#xD;
          -  Up to date with recommended screening mammography within one year&#xD;
&#xD;
          -  Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent&#xD;
             diabetes or hyperlipidemia; and weight ≤ 400 lbs&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Willingness to change diet, physical activity, track behaviors, engage in weekly and&#xD;
             monthly contacts and visit, and take chronic weight loss medication&#xD;
&#xD;
          -  Able to read and write the English language without assistance and daily access to the&#xD;
             e-mail and/or smartphone&#xD;
&#xD;
          -  Patient is aware of her diagnosis, understands the study regimen, its requirements,&#xD;
             risks, and discomforts, and is able and willing to sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious/uncontrolled medical condition at the discretion of the Protocol&#xD;
             Chair/designee likely to hinder accurate measurement of weight or any condition for&#xD;
             which weight loss is contraindicated or would affect adipokine and inflammatory&#xD;
             markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis,&#xD;
             autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and&#xD;
             history of bariatric surgery)&#xD;
&#xD;
          -  Pregnant or nursing within past 6 months, or plans to become pregnant in the next year&#xD;
&#xD;
          -  Currently enrolled or planning to enroll in a weight loss program (e.g. Weight&#xD;
             Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss&#xD;
             medication.&#xD;
&#xD;
          -  Diabetes on insulin or sulfonylureas within the past 3 months&#xD;
&#xD;
          -  Unstable psychiatric disorder or bulimia/anorexia nervosa&#xD;
&#xD;
          -  Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol,&#xD;
             benzodiazepine, barbiturate or anti-epileptic drug&#xD;
&#xD;
          -  Use of the following medications are excluded:&#xD;
&#xD;
               -  Monoamine oxidase (MAO) inhibitors (must be &gt;14 days from discontinuation)&#xD;
&#xD;
               -  Thyroid medication use unless on stable doses for at least the past 3 months&#xD;
&#xD;
               -  Buproprion containing products or opiate agonists (must be &gt;14 days from&#xD;
                  discontinuation)&#xD;
&#xD;
               -  Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat,&#xD;
                  Qsymia, Contrave) within the past 3 months&#xD;
&#xD;
               -  Medications that are likely to cause weight gain or prevent weight loss (e.g.,&#xD;
                  corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive&#xD;
                  pills, hormone replacement therapy) within the past 3 months. NOTE: An exception&#xD;
                  to this is that SSRI's and SNRI's are allowed if participant has been on stable&#xD;
                  doses for at least 3 months (if discontinued, a washout of 2 weeks from prior&#xD;
                  selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake&#xD;
                  inhibitor (SNRI) use is required).&#xD;
&#xD;
               -  Medications that may affect adipokine or inflammatory markers (e.g., metformin,&#xD;
                  glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta&#xD;
                  blockers and statins) unless on stable doses ≥3 months prior to registration (if&#xD;
                  discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs&#xD;
                  are allowed if use is limited to &lt;3 times per week; chronic NSAIDs are permitted&#xD;
                  on study only if use has been ≥3 times per week for at least 3 months prior to&#xD;
                  registration and is expected to continue.&#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>Jennifer Sheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 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>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion hydrochloride, naltrexone hydrochoride drug combination</mesh_term>
    <mesh_term>Naltrexone</mesh_term>
    <mesh_term>Bupropion</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04499950
org study id: IRB00223131
nct id: NCT04499950
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a single arm phase II study designed to determine the effects of pharmacotherapy and
      a remote behavioral weight loss intervention on weight loss in breast cancer survivors who
      are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut
      microbiome.
The investigators will evaluate the extent to which implementation of a chronic weight loss
      medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss.
      All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have
      a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral
      coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9,
      those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while
      those who lose <5%, designated slow responders, will continue BWL and initiate Contrave
      (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug
      Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5%
      weight loss is not achieved at month 6. During month 3, all participants continue to have
      weekly calls with the behavioral coach and will be asked about symptoms, which may be related
      to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation.
      In addition to total weight loss, the investigators will evaluate biomarkers associated with
      obesity, microbiome and cardiometabolic factors.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Number of patients with 5 percent weight loss (in SLOW-BWL)
time frame: 6 months
description: To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.
measure: Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in HbA1c levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in IGF1 levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
measure: Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Fasting glucose levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Fasting lipids levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: 6 Months
description: To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Fasting insulin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Leptin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
measure: Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Microbiome composition among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in NCI quick food scan comparison among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
measure: Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
time frame: Baseline, 2 months and 6 Months
description: To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.
measure: Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
time frame: Baseline, 2 months and 6 Months
description: To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.
measure: Change in Minutes of Moderate to Vigorous Physical Activity (MVPA)
time frame: Baseline, 2 months and 6 Months
description: To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.
measure: Change in Number of daily steps
time frame: Baseline, 2 months and 6 Months
description: To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.
measure: Number of patients with 5% weight loss (in FAST-BWL)
time frame: 6 months
description: To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.
measure: Number of participants with AA genotype and 5% weight loss
time frame: 6 months
description: To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve ≥5% weight loss and improvement in biomarkers at 6 months compared to the women who do not.
measure: Number of participants with AA genotype and Contrave
time frame: 6 months
description: To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave.
arm group label: SLOW-BWL
arm group type: Experimental
description: All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.
arm group label: FAST-BWL
arm group type: Active Comparator
description: All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)
intervention type: Drug
intervention name: Contrave
description: Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.
arm group label: SLOW-BWL
other name: Naltrexone/Bupropion
intervention type: Behavioral
intervention name: Behavioral Weight Loss
description: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.
arm group label: FAST-BWL
arm group label: SLOW-BWL
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Sheng
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Overweight
mesh term: Weight Loss
mesh term: Bupropion hydrochloride, naltrexone hydrochoride drug combination
mesh term: Naltrexone
mesh term: Bupropion