<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/NCT04493879</url>
  </required_header>
  <id_info>
    <org_study_id>68</org_study_id>
    <nct_id>NCT04493879</nct_id>
  </id_info>
  <brief_title>Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis</brief_title>
  <official_title>Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after&#xD;
      receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common&#xD;
      and severe acute side-effect of many oncologic treatments, especially in patients treated for&#xD;
      head and neck cancer. It affects quality of life and require supportive care and proper&#xD;
      treatment plane.&#xD;
&#xD;
      This study had been conducted on thirty cancer patients (head &amp;neck) receiving chemotherapy &amp;&#xD;
      radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and&#xD;
      more), their age ranged from 35 to 55 years, capable of understanding the study assessment&#xD;
      method and willing to complete the current study, they were free from any immunodeficiency&#xD;
      disorders or diseases that could impair the healing process and impact the results as&#xD;
      diabetes mellitus. Patients were randomly allocated from patients from the National Cancer&#xD;
      Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients&#xD;
      receiving BLT for about 10 minutes every day for thirty days in addition to routine oral&#xD;
      mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment&#xD;
      for any new mouth infections), Group B (Control group): This group consisted of 15 patients&#xD;
      receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment&#xD;
      and antimicrobial treatment for any new mouth infections) for thirty days The methods of&#xD;
      evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common&#xD;
      toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized&#xD;
      light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by&#xD;
      WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment&#xD;
      to measure improvement in oral mucositis.&#xD;
&#xD;
      The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)&#xD;
      were assessed first at the beginning of the study and one month after the end of the study;&#xD;
      calculation of mean, standard deviation, minimum and maximum for each group was done by&#xD;
      descriptive statistics, means comparison between the two groups pre and post-application and&#xD;
      within each group was made using The t-test. With a level of significance Alpha point of 0.05&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 20, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Ulceration</measure>
    <time_frame>30 days</time_frame>
    <description>WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Oral Mucositis (Ulcerative)</condition>
  <arm_group>
    <arm_group_label>Bioptron Light Therapy (BLT) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received Bioptron Light Therapy (BLT) ten minutes every day for one month plus the routine medical treatment of oral mucositis(Analgesics, anti-inflammatory medication and antimicrobial therapy for any new mouth infections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine medical care group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received only the routine medical care of oral mucositis for one month this consists of analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bioptron Light Therapy (BLT)</intervention_name>
    <description>BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)</description>
    <arm_group_label>Bioptron Light Therapy (BLT) group</arm_group_label>
    <arm_group_label>Routine medical care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer patients (head &amp;neck) receiving chemotherapy &amp; radiotherapy&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age ranged from 35-55 years&#xD;
&#xD;
          -  All patients capable of understanding the study assessment method and willing to&#xD;
             complete the current study&#xD;
&#xD;
          -  Patients free from any immunodeficiency disorders or diseases that could impair the&#xD;
             healing process and impact the results as diabetes .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from immunodeficiency disorders or diseases that could impair the&#xD;
             healing process and impact the results as diabetes .&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marwa Eid</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ass.Prof</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marwa Eid</name>
      <address>
        <city>Cairo</city>
        <zip>2011</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Eid</investigator_full_name>
    <investigator_title>assistant professor of physical therapy for surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Stomatitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04493879
org study id: 68
nct id: NCT04493879
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after
      receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common
      and severe acute side-effect of many oncologic treatments, especially in patients treated for
      head and neck cancer. It affects quality of life and require supportive care and proper
      treatment plane.

      This study had been conducted on thirty cancer patients (head &neck) receiving chemotherapy &
      radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and
      more), their age ranged from 35 to 55 years, capable of understanding the study assessment
      method and willing to complete the current study, they were free from any immunodeficiency
      disorders or diseases that could impair the healing process and impact the results as
      diabetes mellitus. Patients were randomly allocated from patients from the National Cancer
      Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients
      receiving BLT for about 10 minutes every day for thirty days in addition to routine oral
      mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment
      for any new mouth infections), Group B (Control group): This group consisted of 15 patients
      receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment
      and antimicrobial treatment for any new mouth infections) for thirty days The methods of
      evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common
      toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized
      light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by
      WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment
      to measure improvement in oral mucositis.

      The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
      were assessed first at the beginning of the study and one month after the end of the study;
      calculation of mean, standard deviation, minimum and maximum for each group was done by
      descriptive statistics, means comparison between the two groups pre and post-application and
      within each group was made using The t-test. With a level of significance Alpha point of 0.05
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oral Ulceration
time frame: 30 days
description: WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
arm group label: Bioptron Light Therapy (BLT) group
arm group type: Experimental
description: Received Bioptron Light Therapy (BLT) ten minutes every day for one month plus the routine medical treatment of oral mucositis(Analgesics, anti-inflammatory medication and antimicrobial therapy for any new mouth infections
arm group label: Routine medical care group
arm group type: Experimental
description: Received only the routine medical care of oral mucositis for one month this consists of analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections
intervention type: Other
intervention name: Bioptron Light Therapy (BLT)
description: BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)
arm group label: Bioptron Light Therapy (BLT) group
arm group label: Routine medical care group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: No
last name: Marwa Eid
role: Principal Investigator
affiliation: Ass.Prof
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Eid
investigator title: assistant professor of physical therapy for surgery
mesh term: Mucositis
mesh term: Stomatitis