<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/NCT02234479</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00058645</org_study_id>
    <nct_id>NCT02234479</nct_id>
  </id_info>
  <brief_title>MediHoney for Radiation Dermatitis</brief_title>
  <official_title>A Pilot Study: Topical Application of Medihoney for Management of Radiation Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation&#xD;
      dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It&#xD;
      is hoped that the outcome of this pilot study will provide evidence supporting the use of&#xD;
      Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary&#xD;
      data to expand this study to larger, federally funded research (R01) looking at the&#xD;
      beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in&#xD;
      several disease settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Radiation dermatitis, also known as radiodermatitis or radiation skin reaction,&#xD;
      is a widely reported side effect of radiation therapy in cancer. The most common radiation&#xD;
      therapy-induced side effect is acute skin reaction, which can range from mild erythema to&#xD;
      confluent moist desquamation. Almost all patients receiving radiation therapy have a risk of&#xD;
      developing radiation dermatitis (Trueman, 2012).&#xD;
&#xD;
      When not managed appropriately, radiation dermatitis can affect patients' physical&#xD;
      functioning and quality of life. It can also cause pain and discomfort and may result in&#xD;
      infection and/or interruption of treatment (Feight et al., 2011). An important role for&#xD;
      oncology nurses is in educating, assessing, and monitoring patients for radiation dermatitis.&#xD;
      Many nursing interventions are in use, including those based on tradition, physician&#xD;
      preference, and published reports. In routine practice, most interventions for radiation&#xD;
      dermatitis are institution-specific and not reliably evidence based.&#xD;
&#xD;
      At the investigators institution, Hydrophor (Aquaphor), an ointment containing petrolatum,&#xD;
      mineral oil, ceresin, and lanolin alcohol is the current standard of care for preventing and&#xD;
      treating radiation dermatitis. Some women under treatment for breast cancer report disliking&#xD;
      the smell and/or texture of Hydrophor. Rarely reported side effects have included allergic&#xD;
      reactions, burning, stinging, and/or redness. Honey is an ancient remedy that has most&#xD;
      recently shown promising results in treating burns, oral infections, and promoting surgical&#xD;
      wound healing and palliation. The topical application of honey has been reported to be&#xD;
      advantageous in radiation mucositis (Biswal et al., 2003). In a continuing effort to identify&#xD;
      those treatment options that can make the investigators patients more comfortable and reduce&#xD;
      complications from radiation dermatitis, the investigators are interested in conducting a&#xD;
      small pilot study comparing the effectiveness of a honey-based treatment (Medihoney) with&#xD;
      that of the investigators current standard of care (Hydrophor).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy</measure>
    <time_frame>12 months</time_frame>
    <description>The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Radiation Dermatitis</condition>
  <arm_group>
    <arm_group_label>Hydrophor (Group A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MediHoney (Group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hydrophor (Group A)</intervention_name>
    <description>Rehydrates dry, chapped or chafed skin&#xD;
May be used alone as a skin lubricant or protectant</description>
    <arm_group_label>Hydrophor (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MediHoney (Group B)</intervention_name>
    <description>It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:&#xD;
Maintain a balanced environment for healing.&#xD;
Aids in reducing dermatitis.&#xD;
Reduce affected area pH.2-3</description>
    <arm_group_label>MediHoney (Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer treated with either lumpectomy or mastectomy (with or without&#xD;
             reconstruction).&#xD;
&#xD;
          -  The patient must be female.&#xD;
&#xD;
          -  Radiation therapy planned to whole breast/chestwall area (can include lymph node&#xD;
             radiation; conventional 3D radiation, IMRT/IGRT, and hypofractionation are all&#xD;
             allowed).&#xD;
&#xD;
          -  Age ≥ 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous radiation therapy to chest area that would result in overlapping radiation&#xD;
             fields.&#xD;
&#xD;
          -  Wound care issues.&#xD;
&#xD;
          -  Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy&#xD;
             (concurrent Herceptin and/or tamoxifen/aromatase inhibitors and RT is allowed).&#xD;
&#xD;
          -  Patients receiving HDR (savi or mammosite) brachytherapy treatments.&#xD;
&#xD;
          -  Patients with an allergy and/or sensitivity to Hydrophor, honey, and/or Medihoney.&#xD;
&#xD;
          -  Immunocompromised status.&#xD;
&#xD;
          -  Age &lt; 18 years old.&#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>Elizabeth Nichols, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, College Park</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>February 23, 2016</results_first_submitted>
  <results_first_submitted_qc>June 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 8, 2016</results_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Department of Radiation Oncology</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Radiation Dermatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hydrophor (Group A)</title>
          <description>Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin&#xD;
•May be used alone as a skin lubricant or protectant</description>
        </group>
        <group group_id="P2">
          <title>MediHoney (Group B)</title>
          <description>Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:&#xD;
Maintain a balanced environment for healing.&#xD;
Aids in reducing dermatitis.&#xD;
Reduce affected area pH.2-3</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hydrophor (Group A)</title>
          <description>Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin&#xD;
•May be used alone as a skin lubricant or protectant</description>
        </group>
        <group group_id="B2">
          <title>MediHoney (Group B)</title>
          <description>Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:&#xD;
Maintain a balanced environment for healing.&#xD;
Aids in reducing dermatitis.&#xD;
Reduce affected area pH.2-3</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="34"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="18" upper_limit="75"/>
                    <measurement group_id="B2" value="40" lower_limit="18" upper_limit="75"/>
                    <measurement group_id="B3" value="40" lower_limit="18" upper_limit="75"/>
                  </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="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy</title>
        <description>The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.</description>
        <time_frame>12 months</time_frame>
        <population>Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.</population>
        <group_list>
          <group group_id="O1">
            <title>Hydrophor (Group A)</title>
            <description>Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin&#xD;
•May be used alone as a skin lubricant or protectant</description>
          </group>
          <group group_id="O2">
            <title>MediHoney (Group B)</title>
            <description>Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:&#xD;
Maintain a balanced environment for healing.&#xD;
Aids in reducing dermatitis.&#xD;
Reduce affected area pH.2-3</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy</title>
          <description>The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.</description>
          <population>Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>radiation dermatitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hyperpigmentation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected in a 6 month period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hydrophor (Group A)</title>
          <description>Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin&#xD;
•May be used alone as a skin lubricant or protectant</description>
        </group>
        <group group_id="E2">
          <title>MediHoney (Group B)</title>
          <description>Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.&#xD;
MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:&#xD;
Maintain a balanced environment for healing.&#xD;
Aids in reducing dermatitis.&#xD;
Reduce affected area pH.2-3</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 10.0</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="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Elizabeth Nichols, MD</name_or_title>
      <organization>University of Maryland</organization>
      <phone>410-328-2324</phone>
      <email>enichols1@umm.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/NCT02234479
org study id: HP-00058645
nct id: NCT02234479
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation
      dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It
      is hoped that the outcome of this pilot study will provide evidence supporting the use of
      Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary
      data to expand this study to larger, federally funded research (R01) looking at the
      beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in
      several disease settings.
Background: Radiation dermatitis, also known as radiodermatitis or radiation skin reaction,
      is a widely reported side effect of radiation therapy in cancer. The most common radiation
      therapy-induced side effect is acute skin reaction, which can range from mild erythema to
      confluent moist desquamation. Almost all patients receiving radiation therapy have a risk of
      developing radiation dermatitis (Trueman, 2012).

      When not managed appropriately, radiation dermatitis can affect patients' physical
      functioning and quality of life. It can also cause pain and discomfort and may result in
      infection and/or interruption of treatment (Feight et al., 2011). An important role for
      oncology nurses is in educating, assessing, and monitoring patients for radiation dermatitis.
      Many nursing interventions are in use, including those based on tradition, physician
      preference, and published reports. In routine practice, most interventions for radiation
      dermatitis are institution-specific and not reliably evidence based.

      At the investigators institution, Hydrophor (Aquaphor), an ointment containing petrolatum,
      mineral oil, ceresin, and lanolin alcohol is the current standard of care for preventing and
      treating radiation dermatitis. Some women under treatment for breast cancer report disliking
      the smell and/or texture of Hydrophor. Rarely reported side effects have included allergic
      reactions, burning, stinging, and/or redness. Honey is an ancient remedy that has most
      recently shown promising results in treating burns, oral infections, and promoting surgical
      wound healing and palliation. The topical application of honey has been reported to be
      advantageous in radiation mucositis (Biswal et al., 2003). In a continuing effort to identify
      those treatment options that can make the investigators patients more comfortable and reduce
      complications from radiation dermatitis, the investigators are interested in conducting a
      small pilot study comparing the effectiveness of a honey-based treatment (Medihoney) with
      that of the investigators current standard of care (Hydrophor).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy
time frame: 12 months
description: The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.
arm group label: Hydrophor (Group A)
arm group type: Active Comparator
description: Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
arm group label: MediHoney (Group B)
arm group type: Experimental
description: Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
intervention type: Biological
intervention name: Hydrophor (Group A)
description: Rehydrates dry, chapped or chafed skin
May be used alone as a skin lubricant or protectant
arm group label: Hydrophor (Group A)
intervention type: Biological
intervention name: MediHoney (Group B)
description: It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:
Maintain a balanced environment for healing.
Aids in reducing dermatitis.
Reduce affected area pH.2-3
arm group label: MediHoney (Group B)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Nichols, MD
role: Principal Investigator
affiliation: University of Maryland, College Park
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Department of Radiation Oncology
investigator title: Principle Investigator
mesh term: Dermatitis
mesh term: Radiodermatitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 