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/NCT06029231</url>
    </required_header>
    <id_info>
      <org_study_id>CMUH112-REC1-120</org_study_id>
      <nct_id>NCT06029231</nct_id>
    </id_info>
    <brief_title>Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models</brief_title>
    <official_title>Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China Medical University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China Medical University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Breast cancer has the highest incidence rate among female cancers, and breast radiotherapy&#xD;
        plays an essential role in the treatment of breast cancer. However, the acute and chronic&#xD;
        skin reactions caused by radiotherapy, especially radiation dermatitis, have a significant&#xD;
        impact on the physical and mental health of breast cancer patients. Severe acute radiation&#xD;
        dermatitis can affect the patient's quality of life and may even lead to treatment&#xD;
        interruption, thereby affecting treatment efficacy. Chronic radiation dermatitis can lead to&#xD;
        irreversible skin problems, such as &quot;radiation-irritated skin&quot; and skin pigmentation, which&#xD;
        can affect the quality of life of breast cancer patients after treatment.&#xD;
  &#xD;
        This study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who&#xD;
        underwent whole-breast radiotherapy after breast conserving surgery. The subjects returned to&#xD;
        the hospital for evaluation every week during radiotherapy, and in the second and sixth weeks&#xD;
        after the end of the treatment, they received physical examinations and surveys, including&#xD;
        questionnaire surveys, skin observations and measurements. The study lasted for 3 months.&#xD;
        Skin observation items included physiological parameters such as skin moisture, temperature,&#xD;
        melanin, transepidermal water loss (TEWL), and clinical evaluation of skin reactions by&#xD;
        physicians. Through statistical analysis of skin physiological parameters, scientific&#xD;
        instruments can quantify the radiation skin reactions traditionally judged by clinical&#xD;
        physicians by visual examination and can perform real-time clinical prediction monitoring,&#xD;
        which can be used to establish a skin reaction prediction model in the future.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The worst skin toxicity according to CTCAE grading.</measure>
      <time_frame>1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later</time_frame>
      <description>The worst skin toxicity during radiotherapy and 2 weeks after according to CTCAE grading.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To compare the skin moisture percentage.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the skin trans-epidermal water loss.</measure>
      <time_frame>1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the skin temperature of target region.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of quality of life with the Skindex-16 questionnaire performed every two weeks.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>The score of quality of life with the Skindex-16 questionnaire performed every two weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median time to G2 radiation dermatitis development</measure>
      <time_frame>1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>Median time to G2 radiation dermatitis development</description>
    </secondary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Breast Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be&#xD;
          treated by radiotherapy after operation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be males or non-pregnant females at least 18 years of age.&#xD;
  &#xD;
            -  Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which&#xD;
               will be treated by radiotherapy after operation.&#xD;
  &#xD;
            -  Patient had unilateral breast conservation surgery with or without adjuvant or&#xD;
               neoadjuvant chemotherapy or hormonal treatment.&#xD;
  &#xD;
            -  Patients were scheduled to receive at least five sessions of radiotherapy per week (1&#xD;
               session per day) for at least four weeks using standard irradiation fraction (with at&#xD;
               least 1.8 Gy per session) for total dose of at least 45 Gy.&#xD;
  &#xD;
            -  Participant must give informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bilateral breast cancer&#xD;
  &#xD;
            -  Previous radiotherapy to the chest&#xD;
  &#xD;
            -  Prior breast reconstructions, implants, and/or expanders&#xD;
  &#xD;
            -  Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)&#xD;
  &#xD;
            -  Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or&#xD;
               systemic lupus erythematosus (SLE)&#xD;
  &#xD;
            -  Participation in any clinical trial in the prior 30 days from baseline.&#xD;
  &#xD;
            -  Any condition that, in the judgement of the investigator could impose hazards to the&#xD;
               patient if study therapy is initiated or affect the participation of the patient in&#xD;
               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>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
      <investigator_full_name>Chin-Nan Chu</investigator_full_name>
      <investigator_title>Attending physician</investigator_title>
    </responsible_party>
    <keyword>radiation-irritated skin</keyword>
    <keyword>Radiation therapy</keyword>
    <!-- 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/NCT06029231
  org study id: CMUH112-REC1-120
  nct id: NCT06029231
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer has the highest incidence rate among female cancers, and breast radiotherapy
        plays an essential role in the treatment of breast cancer. However, the acute and chronic
        skin reactions caused by radiotherapy, especially radiation dermatitis, have a significant
        impact on the physical and mental health of breast cancer patients. Severe acute radiation
        dermatitis can affect the patient's quality of life and may even lead to treatment
        interruption, thereby affecting treatment efficacy. Chronic radiation dermatitis can lead to
        irreversible skin problems, such as "radiation-irritated skin" and skin pigmentation, which
        can affect the quality of life of breast cancer patients after treatment.
  
        This study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who
        underwent whole-breast radiotherapy after breast conserving surgery. The subjects returned to
        the hospital for evaluation every week during radiotherapy, and in the second and sixth weeks
        after the end of the treatment, they received physical examinations and surveys, including
        questionnaire surveys, skin observations and measurements. The study lasted for 3 months.
        Skin observation items included physiological parameters such as skin moisture, temperature,
        melanin, transepidermal water loss (TEWL), and clinical evaluation of skin reactions by
        physicians. Through statistical analysis of skin physiological parameters, scientific
        instruments can quantify the radiation skin reactions traditionally judged by clinical
        physicians by visual examination and can perform real-time clinical prediction monitoring,
        which can be used to establish a skin reaction prediction model in the future.
  observational model: Case-Only
  time perspective: Prospective
  measure: The worst skin toxicity according to CTCAE grading.
  time frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
  description: The worst skin toxicity during radiotherapy and 2 weeks after according to CTCAE grading.
  measure: To compare the skin moisture percentage.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: To compare the skin trans-epidermal water loss.
  time frame: 1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: To compare the skin temperature of target region.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
  measure: Median time to G2 radiation dermatitis development
  time frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: Median time to G2 radiation dermatitis development
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: China Medical University Hospital
  investigator full name: Chin-Nan Chu
  investigator title: Attending physician