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/NCT06006806</url>
    </required_header>
    <id_info>
      <org_study_id>2023-474 INV</org_study_id>
      <nct_id>NCT06006806</nct_id>
    </id_info>
    <brief_title>Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy</brief_title>
    <official_title>Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thompson Cancer Survival Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thompson Cancer Survival Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This purpose of this study is to examine skin reactions (called radiation dermatitis) that&#xD;
        occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique&#xD;
        technique called &quot;Spot Delete&quot; to see if it can reduce skin reactions for breast patients&#xD;
        treated with PBS. They will also use a special computer model to study how the energy of the&#xD;
        proton beam (linear energy transfer) is related to these skin reactions. The study involves&#xD;
        creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.&#xD;
        The clinical team uses this CT scan to find the best placement for the protons. The &quot;Spot&#xD;
        Delete&quot; method prevents protons from stopping in the skin, which is thought to cause skin&#xD;
        redness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the study, digital photos of patients' skin will be taken to assess the amount of&#xD;
        redness, without revealing their identity. Patients will be given a self-report questionnaire&#xD;
        and medical staff will document the skin reactions in the patients' medical charts. The&#xD;
        degree of skin reactions will be compared against historical occurrence rates, and the&#xD;
        location of any skin reactions that occur will be compared against the predicted location&#xD;
        from the computer model. In this study, we aim to test the hypothesis that the &quot;Spot Delete&quot;&#xD;
        technique in proton therapy reduces radiation dermatitis in breast cancer patients compared&#xD;
        to historical data from patients who underwent regular proton therapy without the technique.&#xD;
        To evaluate this, we will compare the extent of skin reactions in patients who receive proton&#xD;
        therapy with the &quot;Spot Delete&quot; technique to historical data from patients who did not receive&#xD;
        this treatment.&#xD;
  &#xD;
        The effectiveness of the technique will be evaluated by measuring and documenting the degree&#xD;
        of skin reactions in patients undergoing proton therapy with the Spot Delete technique.&#xD;
        Digital photographs of the treatment area will be taken to assess radiation dermatitis using&#xD;
        the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 and&#xD;
        using the Radiation Dermatitis Severity (RDS) scoring system. Radiation dermatitis will be&#xD;
        assessed at baseline, weekly after every fifth treatment session, at the end of treatment,&#xD;
        and at 2 post treatment follow-up appointments (e.g. 1-month and 6-months post&#xD;
        treatment).These results will be compared to historical occurrence rates of skin reactions in&#xD;
        regular proton therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">July 7, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 7, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The goal of this study is to measure skin reactions during proton therapy for 100 patients over a period of three years.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction in Radiation Dermatitis</measure>
      <time_frame>weekly assessments over 10 weeks</time_frame>
      <description>&quot;Spot Delete&quot; technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>linear energy transfer (LET) of the proton beam</measure>
      <time_frame>LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.</time_frame>
      <description>A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Breast Cancer Stage II</condition>
    <condition>Breast Cancer Stage III</condition>
    <condition>Breast Cancer Stage I</condition>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Pencil Beam Scanning Proton Therapy</intervention_name>
      <description>Part of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called &quot;Spot Delete&quot; to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process.</description>
      <other_name>Spot Delete</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • The patient must consent to be in the study and must have signed an approved consent&#xD;
               form conforming to federal and institutional guidelines.&#xD;
  &#xD;
                 -  Patients must be 18 years old.&#xD;
  &#xD;
                 -  The patient must have stage 0, I, II, or III breast cancer&#xD;
  &#xD;
                 -  On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or&#xD;
                    invasive adenocarcinoma of the breast&#xD;
  &#xD;
                 -  Surgical treatment of the breast must have been lumpectomy or mastectomy&#xD;
  &#xD;
                 -  Patients must have an estrogen receptor (ER) analysis performed on the primary&#xD;
                    tumor&#xD;
  &#xD;
                 -  Progesterone (PgR) analysis is desired but not mandatory&#xD;
  &#xD;
                 -  Patients with a history of non-breast malignancies are eligible if they have been&#xD;
                    disease-free for 5 or more years&#xD;
  &#xD;
                 -  No serious health conditions as determined by physician that would impact ability&#xD;
                    to complete treatment or impact skin in the area of treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Stage IV breast cancer&#xD;
  &#xD;
                 -  Non-epithelial breast malignancies such as sarcoma or lymphoma&#xD;
  &#xD;
                 -  Paget's disease of the nipple&#xD;
  &#xD;
                 -  Prior breast or thoracic radiation therapy (RT) for any condition.&#xD;
  &#xD;
                 -  Collagen vascular disease, specifically dermatomyositis with a Creatine&#xD;
                    phosphokinase (CPK) level above normal or with an active skin rash, systemic&#xD;
                    lupus erythematosis, or scleroderma.&#xD;
  &#xD;
                 -  Pregnancy or lactation&#xD;
  &#xD;
                 -  Psychiatric or addictive disorders or other conditions that, in the opinion of&#xD;
                    the investigator, would preclude the patient from meeting the study requirements.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Men are not eligible for this study</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samantha Hedrick, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Director of Medical Physics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Director of Medical Physics</last_name>
      <phone>865-862-1600</phone>
      <email>shedrick@covhlth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chester Ramsey, PhD</last_name>
      <phone>865-331-3161</phone>
      <email>cramsey@covhlth.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Thompson Proton Center</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37909</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Casey Mastio-Partridge, BS, MLS</last_name>
        <phone>865-331-8216</phone>
        <email>cmastio@covhlth.com</email>
      </contact>
      <contact_backup>
        <last_name>Jessica M Severt, RN, BSN</last_name>
        <phone>865-331-4966</phone>
        <email>jsevert@covhlth.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ryan Grover, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brion Shin, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Allen Meek, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Chester Ramsey, Ph.D</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Samantha Hedrick, Ph.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006806
  org study id: 2023-474 INV
  nct id: NCT06006806
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  This purpose of this study is to examine skin reactions (called radiation dermatitis) that
        occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique
        technique called "Spot Delete" to see if it can reduce skin reactions for breast patients
        treated with PBS. They will also use a special computer model to study how the energy of the
        proton beam (linear energy transfer) is related to these skin reactions. The study involves
        creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.
        The clinical team uses this CT scan to find the best placement for the protons. The "Spot
        Delete" method prevents protons from stopping in the skin, which is thought to cause skin
        redness.
  During the study, digital photos of patients' skin will be taken to assess the amount of
        redness, without revealing their identity. Patients will be given a self-report questionnaire
        and medical staff will document the skin reactions in the patients' medical charts. The
        degree of skin reactions will be compared against historical occurrence rates, and the
        location of any skin reactions that occur will be compared against the predicted location
        from the computer model. In this study, we aim to test the hypothesis that the "Spot Delete"
        technique in proton therapy reduces radiation dermatitis in breast cancer patients compared
        to historical data from patients who underwent regular proton therapy without the technique.
        To evaluate this, we will compare the extent of skin reactions in patients who receive proton
        therapy with the "Spot Delete" technique to historical data from patients who did not receive
        this treatment.
  
        The effectiveness of the technique will be evaluated by measuring and documenting the degree
        of skin reactions in patients undergoing proton therapy with the Spot Delete technique.
        Digital photographs of the treatment area will be taken to assess radiation dermatitis using
        the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 and
        using the Radiation Dermatitis Severity (RDS) scoring system. Radiation dermatitis will be
        assessed at baseline, weekly after every fifth treatment session, at the end of treatment,
        and at 2 post treatment follow-up appointments (e.g. 1-month and 6-months post
        treatment).These results will be compared to historical occurrence rates of skin reactions in
        regular proton therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The goal of this study is to measure skin reactions during proton therapy for 100 patients over a period of three years.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Reduction in Radiation Dermatitis
  time frame: weekly assessments over 10 weeks
  description: "Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.
  measure: linear energy transfer (LET) of the proton beam
  time frame: LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.
  description: A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model
  intervention type: Radiation
  intervention name: Pencil Beam Scanning Proton Therapy
  description: Part of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called "Spot Delete" to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process.
  other name: Spot Delete
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Men are not eligible for this study
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Samantha Hedrick, PhD
  role: Principal Investigator
  affiliation: Director of Medical Physics
  last name: Director of Medical Physics
  phone: 865-862-1600
  email: shedrick@covhlth.com
  last name: Chester Ramsey, PhD
  phone: 865-331-3161
  email: cramsey@covhlth.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No