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/NCT06023576</url>
    </required_header>
    <id_info>
      <org_study_id>23-159</org_study_id>
      <nct_id>NCT06023576</nct_id>
    </id_info>
    <brief_title>A Study of Blood Pressure Control During Cancer Treatment</brief_title>
    <official_title>Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study to find out whether an intensive approach to treating high blood&#xD;
        pressure during breast cancer treatment is safe and more effective than standard blood&#xD;
        pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in&#xD;
        patients with cancer. Other studies have shown lowering blood pressure improves the health of&#xD;
        patients. However, these studies have not included people with cancer.&#xD;
  &#xD;
        The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP&#xD;
        goals, and is not testing specific medications.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">August 18, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 18, 2027</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>This open-label, two-arm RCT will compare the effects of intensive versus standard SBP control in patients with BC and HTN receiving anthracycline-based treatment (with or without HER2-targeted therapy).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mean change in systolic blood pressure (SBP) from baseline to 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>based upon in-office measurement</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Cardiotoxicity</condition>
    <arm_group>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to intensive SBP control will be treated to achieve an SBP goal &lt;120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal &lt;140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>antihypertensive medications</intervention_name>
      <description>One or more of the following medications may be used in both randomization groups to achieve SBP goals:&#xD;
  Angiotensin converting enzyme inhibitors (ACEI)&#xD;
  Angiotensin receptor blockers (ARBs)&#xD;
  Beta-blockers (BB)&#xD;
  Thiazide-type diuretics&#xD;
  Calcium channel blockers&#xD;
  Aldosterone antagonists&#xD;
  Alpha1-receptor blockers.&#xD;
  Direct vasodilators&#xD;
  Loop diuretics</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood pressure measurement</intervention_name>
      <description>Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Echocardiogram</intervention_name>
      <description>At baseline, month 6, and month 12</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Symptom-limited cardiopulmonary exercise test</intervention_name>
      <description>Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality of Life Measures</intervention_name>
      <description>FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Biomarkers</intervention_name>
      <description>Research blood samples will be collected at baseline, 3 months, and 6 months</description>
      <arm_group_label>higher dose antihypertensive medications</arm_group_label>
      <arm_group_label>standard-of-care antihypertensive medications</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Female assigned at birth&#xD;
  &#xD;
            -  Biopsy proven breast cancer (stage I-IV)&#xD;
  &#xD;
            -  Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy,&#xD;
               with or without HER2-targeted therapy)&#xD;
  &#xD;
            -  SBP ≥130 mm Hg&#xD;
  &#xD;
            -  Willing and able to comply with the requirements of the protocol.&#xD;
  &#xD;
            -  Participant must have and be willing to use their bluetooth enabled wifi or cellular&#xD;
               mobile device&#xD;
  &#xD;
            -  (For participants in the CPET cohort): Able to complete an acceptable baseline CPET,&#xD;
               in the absence of high-risk ECG findings or other inappropriate response to exercise&#xD;
               as determined by the PI, as defined by any of the following criteria:&#xD;
  &#xD;
                 -  Achieving a plateau oxygen consumption, concurrent with an increase in power&#xD;
                    output;&#xD;
  &#xD;
                 -  A respiratory exchange ratio ≥ 1.10;&#xD;
  &#xD;
                 -  Attainment of maximal predicted heart rate, as defined by a peak heart rate&#xD;
                    within 10bpm of the age predicted maximal heart rate (220 - Age[years]);&#xD;
  &#xD;
                 -  Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18&#xD;
                    on the BORG scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  eGFR &lt; 30 ml/min/1.73m2 (based upon Cockcroft-Gault, etc.)&#xD;
  &#xD;
            -  Individuals with arm circumference too large to allow accurate BP measurement with&#xD;
               available BP devices&#xD;
  &#xD;
            -  Inability to accurately measure blood pressure in at least one arm (e.g., bilateral&#xD;
               upper extremity lymphedema)&#xD;
  &#xD;
            -  Cardiac comorbidity, including any of the following:&#xD;
  &#xD;
                 -  Acute coronary syndrome within 3 months prior to randomization.&#xD;
  &#xD;
                 -  Symptomatic heart failure (NYHA class III/IV) within past 6 months&#xD;
  &#xD;
                 -  History of stroke&#xD;
  &#xD;
                 -  Cardiac transplantation&#xD;
  &#xD;
            -  Other medical disorder or condition that in the opinion of the investigator would&#xD;
               impair the subject's ability to participate or adhere to study interventions&#xD;
  &#xD;
            -  (For participants in the CPET cohort): Subjects must not have any of the following&#xD;
               absolute contraindications to cardiopulmonary exercise testing:&#xD;
  &#xD;
                 -  Acute myocardial infarction (within 30 days of any planned study procedures),&#xD;
  &#xD;
                 -  Unstable angina&#xD;
  &#xD;
                 -  Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,&#xD;
  &#xD;
                 -  Symptomatic severe aortic stenosis&#xD;
  &#xD;
                 -  Recurrent syncope&#xD;
  &#xD;
                 -  Active endocarditis&#xD;
  &#xD;
                 -  Acute myocarditis or pericarditis&#xD;
  &#xD;
                 -  Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned&#xD;
                    study procedures)&#xD;
  &#xD;
                 -  Thrombosis of lower extremities (within 3 months of any planned study procedures)&#xD;
  &#xD;
                 -  Suspected dissecting aneurysm&#xD;
  &#xD;
                 -  Uncontrolled asthma&#xD;
  &#xD;
                 -  Pulmonary edema&#xD;
  &#xD;
                 -  Room air desaturation at rest ≤85%&#xD;
  &#xD;
                 -  Respiratory failure&#xD;
  &#xD;
                 -  Acute noncardiopulmonary disorder that may affect exercise performance or be&#xD;
                    aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)&#xD;
  &#xD;
                 -  Mental impairment leading to inability to cooperate.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female assigned at birth</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anthony Yu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anthony Yu, MD</last_name>
      <phone>212-639-7932</phone>
      <email>yua3@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jennifer Liu, MD</last_name>
      <phone>212-639-8220</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Yu, MD</last_name>
        <phone>212-639-7932</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Blood pressure</keyword>
    <keyword>23-159</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Cardiotoxicity</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antihypertensive Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </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/NCT06023576
  org study id: 23-159
  nct id: NCT06023576
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study to find out whether an intensive approach to treating high blood
        pressure during breast cancer treatment is safe and more effective than standard blood
        pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in
        patients with cancer. Other studies have shown lowering blood pressure improves the health of
        patients. However, these studies have not included people with cancer.
  
        The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP
        goals, and is not testing specific medications.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This open-label, two-arm RCT will compare the effects of intensive versus standard SBP control in patients with BC and HTN receiving anthracycline-based treatment (with or without HER2-targeted therapy).
  primary purpose: Prevention
  masking: None (Open Label)
  measure: mean change in systolic blood pressure (SBP) from baseline to 12 months
  time frame: 12 months
  description: based upon in-office measurement
  arm group label: standard-of-care antihypertensive medications
  arm group type: Experimental
  description: This will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
  arm group label: higher dose antihypertensive medications
  arm group type: Experimental
  description: Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
  intervention type: Other
  intervention name: antihypertensive medications
  description: One or more of the following medications may be used in both randomization groups to achieve SBP goals:
  Angiotensin converting enzyme inhibitors (ACEI)
  Angiotensin receptor blockers (ARBs)
  Beta-blockers (BB)
  Thiazide-type diuretics
  Calcium channel blockers
  Aldosterone antagonists
  Alpha1-receptor blockers.
  Direct vasodilators
  Loop diuretics
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  intervention type: Diagnostic Test
  intervention name: Blood pressure measurement
  description: Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  intervention type: Diagnostic Test
  intervention name: Echocardiogram
  description: At baseline, month 6, and month 12
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  intervention type: Other
  intervention name: Symptom-limited cardiopulmonary exercise test
  description: Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  intervention type: Other
  intervention name: Quality of Life Measures
  description: FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  intervention type: Diagnostic Test
  intervention name: Biomarkers
  description: Research blood samples will be collected at baseline, 3 months, and 6 months
  arm group label: higher dose antihypertensive medications
  arm group label: standard-of-care antihypertensive medications
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female assigned at birth
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anthony Yu, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Anthony Yu, MD
  phone: 212-639-7932
  email: yua3@mskcc.org
  last name: Jennifer Liu, MD
  phone: 212-639-8220
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Cardiotoxicity
  mesh term: Antihypertensive Agents
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.