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/NCT06003764</url>
    </required_header>
    <id_info>
      <org_study_id>AhramCU</org_study_id>
      <nct_id>NCT06003764</nct_id>
    </id_info>
    <brief_title>Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients</brief_title>
    <official_title>Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahram Canadian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahram Canadian University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer&#xD;
        patient and post mastectomy patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective is to understand the effect of PEMF on skin thickness and toxicity after&#xD;
        radiotherapy on breast cancer.&#xD;
  &#xD;
        The study will include 50 adult female breast cancer undergoing whole-breast irradiation.&#xD;
  &#xD;
        This is a randomized, controlled clinical trial will conduct at the outpatient clinic of the&#xD;
        Faculty of Physical Therapy, Ahram Canadian University.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>
      <intervention_model_description>randomized, single blinded controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) SCALE</measure>
      <time_frame>pre treatment and post 2 months of treatment</time_frame>
      <description>0 No change&#xD;
  Faint erythema or dry desquamation&#xD;
  Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema&#xD;
  Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion&#xD;
  Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiation Therapy Oncology Group (RTOG) SCALE</measure>
      <time_frame>pre treatment and post 2 months of treatment</time_frame>
      <description>0 No change&#xD;
  Faint erythema or dry desquamation&#xD;
  Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema&#xD;
  Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion&#xD;
  Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Dermatitis, Radiation Induced</condition>
    <arm_group>
      <arm_group_label>Pulsed electromagnetic field group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes) A magnetotherapy device will be used for the PEMFT was ASTAR Magneto-therapy premium (15 Hz, 1.5 mT intensity output for 5 s/min for 20 min. 3 times per week for 8 successive weeks plus the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing). for 8 successive weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>traditional skin care( the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing). for 8 successive weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pulsed electromagnetic field</intervention_name>
      <description>low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)</description>
      <arm_group_label>Pulsed electromagnetic field group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>traditional skin care</intervention_name>
      <description>traditional skin care( the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing</description>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_label>Pulsed electromagnetic field group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.&#xD;
  &#xD;
            -  Unilateral breast cancer&#xD;
  &#xD;
            -  Age from 35-55 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients had previous irradiation to the same breast.&#xD;
  &#xD;
            -  Patients had bilateral breast cancer.&#xD;
  &#xD;
            -  Patients had metastatic disease.&#xD;
  &#xD;
            -  when the use of bolus material was required to deliver RT.&#xD;
  &#xD;
            -  Patients had a pre-existing skin condition or open wound in the treatment area.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>females with Breast cancer</gender_description>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>mahmoud hamada, Assisyant Professor</last_name>
      <phone>01096968910</phone>
      <email>dr.mahmoudhamada@acu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mohamed naeem, Mahmoud Abdel Tawab Mahmoud</last_name>
      <phone>0106739576</phone>
      <email>mohamed.naeem@pt.bsu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>ahram canadian University</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
      <investigator>
        <last_name>mohamed selim, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>mahmoud Abdel Tawab, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Abdelrazak Ahmed, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>mahmoud elshazly, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahram Canadian University</investigator_affiliation>
      <investigator_full_name>Mahmoud H Mohamed, PhD</investigator_full_name>
      <investigator_title>Assistant Professor of Physical Therapy</investigator_title>
    </responsible_party>
    <keyword>PEMFT, DERMATITIS, RADIOTHERAPY</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>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06003764
  org study id: AhramCU
  nct id: NCT06003764
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer
        patient and post mastectomy patients.
  The objective is to understand the effect of PEMF on skin thickness and toxicity after
        radiotherapy on breast cancer.
  
        The study will include 50 adult female breast cancer undergoing whole-breast irradiation.
  
        This is a randomized, controlled clinical trial will conduct at the outpatient clinic of the
        Faculty of Physical Therapy, Ahram Canadian University.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized, single blinded controlled trial
  primary purpose: Treatment
  masking: Single (Participant)
  measure: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) SCALE
  time frame: pre treatment and post 2 months of treatment
  description: 0 No change
  Faint erythema or dry desquamation
  Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema
  Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
  Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
  measure: Radiation Therapy Oncology Group (RTOG) SCALE
  time frame: pre treatment and post 2 months of treatment
  description: 0 No change
  Faint erythema or dry desquamation
  Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema
  Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
  Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
  arm group label: Pulsed electromagnetic field group
  arm group type: Experimental
  description: low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes) A magnetotherapy device will be used for the PEMFT was ASTAR Magneto-therapy premium (15 Hz, 1.5 mT intensity output for 5 s/min for 20 min. 3 times per week for 8 successive weeks plus the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing). for 8 successive weeks
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: traditional skin care( the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing). for 8 successive weeks
  intervention type: Other
  intervention name: Pulsed electromagnetic field
  description: low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)
  arm group label: Pulsed electromagnetic field group
  intervention type: Other
  intervention name: traditional skin care
  description: traditional skin care( the patients will receive the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing will be used. Additionally, the patient will be advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing
  arm group label: Placebo group
  arm group label: Pulsed electromagnetic field group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: females with Breast cancer
  minimum age: 35 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: mahmoud hamada, Assisyant Professor
  phone: 01096968910
  email: dr.mahmoudhamada@acu.edu.eg
  last name: mohamed naeem, Mahmoud Abdel Tawab Mahmoud
  phone: 0106739576
  email: mohamed.naeem@pt.bsu.edu.eg
  facility: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ahram Canadian University
  investigator full name: Mahmoud H Mohamed, PhD
  investigator title: Assistant Professor of Physical Therapy
  mesh term: Dermatitis
  mesh term: Radiodermatitis
  sharing ipd: Undecided