<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/NCT02203565</url>
  </required_header>
  <id_info>
    <org_study_id>BRS0039</org_study_id>
    <secondary_id>NCI-2014-01551</secondary_id>
    <secondary_id>IRB-29833</secondary_id>
    <secondary_id>BRS0039</secondary_id>
    <secondary_id>P30CA124435</secondary_id>
    <nct_id>NCT02203565</nct_id>
  </id_info>
  <brief_title>Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy</brief_title>
  <official_title>Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in&#xD;
      patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin&#xD;
      condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's&#xD;
      solution may help reduce dermatitis caused by radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis&#xD;
      as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for&#xD;
      breast cancer compared to historical experience using standard skin care.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's&#xD;
      solution), and to assess levels of pain during radiotherapy treatment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of&#xD;
      radiation therapy for up to 6 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4-6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 7, 2016</completion_date>
  <primary_completion_date type="Actual">July 7, 2016</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy</measure>
    <time_frame>Baseline to up to 6 weeks after completion of therapy</time_frame>
    <description>Stanford Radiation Dermatitis Scoring System:&#xD;
Grade Clinical finding&#xD;
0 No skin change&#xD;
1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Skin Reactions Secondary to Radiation Therapy</condition>
  <arm_group>
    <arm_group_label>Supportive care (Dakin's solution, radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dakin's solution</intervention_name>
    <description>Applied topically</description>
    <arm_group_label>Supportive care (Dakin's solution, radiation therapy)</arm_group_label>
    <other_name>aqueous solution of sodium hypochlorite</other_name>
    <other_name>Dakin's fluid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Supportive care (Dakin's solution, radiation therapy)</arm_group_label>
    <other_name>irradiation</other_name>
    <other_name>radiotherapy</other_name>
    <other_name>therapy, radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (Dakin's solution, radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Optional correlative studies</description>
    <arm_group_label>Supportive care (Dakin's solution, radiation therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with breast cancer who plan to undergo radiation therapy to the breast or chest&#xD;
             wall&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with scleroderma or discoid lupus&#xD;
&#xD;
          -  Women with inflammatory breast cancer as evidenced by clinical assessment&#xD;
&#xD;
          -  Women with breast cancer involving the skin&#xD;
&#xD;
          -  Women who have undergone prior radiotherapy to the chest wall and/or breast&#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>Kathleen Horst</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University Hospitals and Clinics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>May 22, 2017</results_first_submitted>
  <results_first_submitted_qc>June 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2017</results_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Kathleen Horst</investigator_full_name>
    <investigator_title>Assistant Professor of Radiation Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Hypochlorite</mesh_term>
    <mesh_term>Eusol</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Supportive Care (Dakin's Solution, Radiation Therapy)</title>
          <description>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.&#xD;
Dakin's solution: Applied topically&#xD;
radiation therapy: Undergo radiation therapy&#xD;
questionnaire administration: Ancillary studies&#xD;
laboratory biomarker analysis: Optional correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Supportive Care (Dakin's Solution, Radiation Therapy)</title>
          <description>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.&#xD;
Dakin's solution: Applied topically&#xD;
radiation therapy: Undergo radiation therapy&#xD;
questionnaire administration: Ancillary studies&#xD;
laboratory biomarker analysis: Optional correlative studies</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy</title>
        <description>Stanford Radiation Dermatitis Scoring System:&#xD;
Grade Clinical finding&#xD;
0 No skin change&#xD;
1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection</description>
        <time_frame>Baseline to up to 6 weeks after completion of therapy</time_frame>
        <population>Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Dakin's Solution, Radiation Therapy)</title>
            <description>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.&#xD;
Dakin's solution: Applied topically&#xD;
radiation therapy: Undergo radiation therapy&#xD;
questionnaire administration: Ancillary studies&#xD;
laboratory biomarker analysis: Optional correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy</title>
          <description>Stanford Radiation Dermatitis Scoring System:&#xD;
Grade Clinical finding&#xD;
0 No skin change&#xD;
1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection</description>
          <population>Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected throughout radiation treatment, approximately 5 weeks, for each patients. For the study overall adverse events were monitored for various patients over the course of 1 year when the study was open to accrual.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Supportive Care (Dakin's Solution, Radiation Therapy)</title>
          <description>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.&#xD;
Dakin's solution: Applied topically&#xD;
radiation therapy: Undergo radiation therapy&#xD;
questionnaire administration: Ancillary studies&#xD;
laboratory biomarker analysis: Optional correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Radiation Dermatitis</sub_title>
                <description>Patients were evaluated for Radiation Dermatitis of all grades (1-4) as defined by CTCAE guidlines. Radiation dermatitis is an expected side effect of radiation therapy and not associated with or an expected reaction to the Dakin's solution.</description>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kathleen Horst</name_or_title>
      <organization>Stanford University School of Medicine</organization>
      <phone>6507256009</phone>
      <email>kateh@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02203565
org study id: BRS0039
secondary id: NCI-2014-01551
secondary id: IRB-29833
secondary id: BRS0039
secondary id: P30CA124435
nct id: NCT02203565
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in
      patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin
      condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's
      solution may help reduce dermatitis caused by radiation therapy.
PRIMARY OBJECTIVES:

      I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis
      as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for
      breast cancer compared to historical experience using standard skin care.

      SECONDARY OBJECTIVES:

      I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's
      solution), and to assess levels of pain during radiotherapy treatment.

      OUTLINE:

      Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of
      radiation therapy for up to 6 weeks.

      After completion of study treatment, patients are followed up at 4-6 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy
time frame: Baseline to up to 6 weeks after completion of therapy
description: Stanford Radiation Dermatitis Scoring System:
Grade Clinical finding
0 No skin change
1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection
arm group label: Supportive care (Dakin's solution, radiation therapy)
arm group type: Experimental
description: Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
intervention type: Drug
intervention name: Dakin's solution
description: Applied topically
arm group label: Supportive care (Dakin's solution, radiation therapy)
other name: aqueous solution of sodium hypochlorite
other name: Dakin's fluid
intervention type: Radiation
intervention name: radiation therapy
description: Undergo radiation therapy
arm group label: Supportive care (Dakin's solution, radiation therapy)
other name: irradiation
other name: radiotherapy
other name: therapy, radiation
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Supportive care (Dakin's solution, radiation therapy)
intervention type: Other
intervention name: laboratory biomarker analysis
description: Optional correlative studies
arm group label: Supportive care (Dakin's solution, radiation therapy)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Horst
role: Principal Investigator
affiliation: Stanford University Hospitals and Clinics
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Kathleen Horst
investigator title: Assistant Professor of Radiation Oncology
mesh term: Breast Neoplasms
mesh term: Dermatitis
mesh term: Radiodermatitis
mesh term: Sodium Hypochlorite
mesh term: Eusol
mesh term: Pharmaceutical Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 