<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/NCT03768492</url>
  </required_header>
  <id_info>
    <org_study_id>18-00309</org_study_id>
    <nct_id>NCT03768492</nct_id>
  </id_info>
  <brief_title>Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy</brief_title>
  <acronym>ReDCoAT</acronym>
  <official_title>A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates&#xD;
      of reconstructive complications in patients with tissue expander based reconstruction&#xD;
      requiring post-mastectomy radiation therapy when compared to a placebo cream.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Toxicity Scoring</measure>
    <time_frame>4 Years</time_frame>
    <description>The US National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE), which was formerly called the Common Toxicity Criteria (CTC), which is a standardized classification of adverse effects in cancer therapy. The current version 5.0 was released in 2017. The criteria uses a grading system of 1 to 5 (e.g. Grade 1 = mild and Grade 5 = death related to AE).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Carcinoma Breast</condition>
  <arm_group>
    <arm_group_label>Caffeine Based Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>caffeine based cream during and for 4 weeks following radiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo cream during and for 4 weeks following radiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caffeine anhydrous 5% added to Lipoderm Cream Base.</intervention_name>
    <description>Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm</description>
    <arm_group_label>Caffeine Based Cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lipoderm Cream Base</intervention_name>
    <description>Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)&#xD;
&#xD;
          -  Patient has undergone mastectomy with tissue expander-based reconstruction and require&#xD;
             post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer,&#xD;
             excluding any patients with inflammatory breast cancer at presentation.&#xD;
&#xD;
          -  Patient will receive irradiation of the chest wall. Additional fields to treat the&#xD;
             regional nodes including the supraclavicular / axillary and/or internal mammary chains&#xD;
             is allowed but not required. If a patient requires a boost field to the chest wall,&#xD;
             scar and/or nodal region this is allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with skin changes or inflammatory carcinoma at presentation Patient has&#xD;
             (cT4b-d)&#xD;
&#xD;
          -  unhealed wound in the radiation field&#xD;
&#xD;
          -  Patient has allergy to Caffeine&#xD;
&#xD;
          -  Patient has systemic lupus erythematosus or scleroderma that increases the risk of&#xD;
             radiation dermatitis development&#xD;
&#xD;
          -  Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to&#xD;
             take concurrent hormonal therapy or Trastuzumab)&#xD;
&#xD;
          -  Planned accelerated or hypofractionated fractionation.&#xD;
&#xD;
          -  Previous radiation to the ipsilateral breast or chest wall or thoracic region.&#xD;
&#xD;
          -  Anyone who will require bolus use during radiation (per physician discretion) as this&#xD;
             will increase rates of acute toxicity interfering with measurement of the primary&#xD;
             study endpoint.&#xD;
&#xD;
          -  All pre-menopausal women will require a urine qualitative pregnancy test to exclude&#xD;
             pregnancy. Pregnant women will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naamit Kurshan Gerber</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Naamit K Gerber, MD</last_name>
    <phone>212 731 5304</phone>
    <email>Naamit.Gerber@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naamit K Gerber, MD</last_name>
      <phone>646-596-8528</phone>
      <email>Naamit.Gerber@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Naamit K Gerber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Masectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Single-institution investigator initiated trial. We are not going to make our data available to others.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03768492
org study id: 18-00309
nct id: NCT03768492
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates
      of reconstructive complications in patients with tissue expander based reconstruction
      requiring post-mastectomy radiation therapy when compared to a placebo cream.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Standard Toxicity Scoring
time frame: 4 Years
description: The US National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE), which was formerly called the Common Toxicity Criteria (CTC), which is a standardized classification of adverse effects in cancer therapy. The current version 5.0 was released in 2017. The criteria uses a grading system of 1 to 5 (e.g. Grade 1 = mild and Grade 5 = death related to AE).
arm group label: Caffeine Based Cream
arm group type: Experimental
description: caffeine based cream during and for 4 weeks following radiation
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo cream during and for 4 weeks following radiation
intervention type: Drug
intervention name: Caffeine anhydrous 5% added to Lipoderm Cream Base.
description: Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
arm group label: Caffeine Based Cream
intervention type: Other
intervention name: Lipoderm Cream Base
description: Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naamit Kurshan Gerber
role: Principal Investigator
affiliation: NYU Langone Medical Center
last name: Naamit K Gerber, MD
phone: 212 731 5304
email: Naamit.Gerber@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Caffeine
sharing ipd: No
ipd description: Single-institution investigator initiated trial. We are not going to make our data available to others.