<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/NCT04482855</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 01320</org_study_id>
    <nct_id>NCT04482855</nct_id>
  </id_info>
  <brief_title>Low-Level Laser in Head and Neck Chronic Lymphedema</brief_title>
  <official_title>Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on&#xD;
      the severity of lymphedema, symptom burden, functional status, and quality of life in HNC&#xD;
      survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in&#xD;
      severity of lymphedema.&#xD;
&#xD;
      Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on&#xD;
      lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of&#xD;
      motion in jaw and neck), and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2021</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2023</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, wait-list control</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of patients with reduced severity of lymphedema and fibrosis</measure>
    <time_frame>Up to 8-week post-LLLT</time_frame>
    <description>Head and Neck Lymphedema and Fibrosis Assessment Criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom burden score</measure>
    <time_frame>Up to 8-week post-LLLT</time_frame>
    <description>Head and Neck Lymphedema and Fibrosis Symptom Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck range of motion degree</measure>
    <time_frame>Up to 8-week post-LLLT</time_frame>
    <description>Cervical Range of Motion Device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>Up to 8-week post-LLLT</time_frame>
    <description>EORTC QLQ-H&amp;N35</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Lymphedema</condition>
  <condition>Fibrosis</condition>
  <arm_group>
    <arm_group_label>Group 1 (laser group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (wait-list control group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low-level laser</intervention_name>
    <description>Low-level laser therapy</description>
    <arm_group_label>Group 1 (laser group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  &gt;6 months post HNC treatment&#xD;
&#xD;
          -  No evidence of cancer confirmed with imaging tests&#xD;
&#xD;
          -  Having head and neck lymphedema with or without fibrosis&#xD;
&#xD;
          -  Completion of initial lymphedema therapy&#xD;
&#xD;
          -  Lymphedema duration between 3-24 months&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they have any of the following medical conditions that would&#xD;
        prohibit the safe implementation of LLLT:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  Photosensitivity&#xD;
&#xD;
          -  Chronic inflammatory diseases&#xD;
&#xD;
          -  Venous thrombosis&#xD;
&#xD;
          -  Carotid artery stenosis&#xD;
&#xD;
          -  History of severe trauma&#xD;
&#xD;
          -  Medication that affects body fluid and electrolyte balance&#xD;
&#xD;
          -  Use of high doses of non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Pre-existing skin rash, ulceration, open wound in the treatment area&#xD;
&#xD;
          -  Active lymphedema therapy or physical therapy&#xD;
&#xD;
          -  Allergic and other systemic skin diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Jie Deng</investigator_full_name>
    <investigator_title>Associate Professor, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04482855
org study id: UPCC 01320
nct id: NCT04482855
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on
      the severity of lymphedema, symptom burden, functional status, and quality of life in HNC
      survivors.
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in
      severity of lymphedema.

      Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on
      lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of
      motion in jaw and neck), and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, wait-list control
primary purpose: Supportive Care
masking: None (Open Label)
measure: % of patients with reduced severity of lymphedema and fibrosis
time frame: Up to 8-week post-LLLT
description: Head and Neck Lymphedema and Fibrosis Assessment Criteria
measure: Symptom burden score
time frame: Up to 8-week post-LLLT
description: Head and Neck Lymphedema and Fibrosis Symptom Inventory
measure: Neck range of motion degree
time frame: Up to 8-week post-LLLT
description: Cervical Range of Motion Device
measure: Quality of life score
time frame: Up to 8-week post-LLLT
description: EORTC QLQ-H&N35
arm group label: Group 1 (laser group)
arm group type: Experimental
description: Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection.
arm group label: Group 2 (wait-list control group)
arm group type: No Intervention
description: Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group.
intervention type: Device
intervention name: Low-level laser
description: Low-level laser therapy
arm group label: Group 1 (laser group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Jie Deng
investigator title: Associate Professor, PhD
mesh term: Lymphedema
sharing ipd: Undecided