<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220220054073N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-27</date_registration>
      <primary_sponsor>Iran National Science Foundation (INSF)</primary_sponsor>
      <public_title>Evaluating the pain relieving effects of Non-Thermal CO2 Laser Therapy (NTCLT)  on chemotherapy induced oral mucositis</public_title>
      <acronym>NTCLT</acronym>
      <scientific_title>Evaluating the pain relieving effects of Non-Thermal CO2 Laser Therapy (NTCLT)  on chemotherapy induced oral mucositis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63766</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Before-After Clinical Trial.</study_design>
      <phase>2</phase>
      <hc_freetext>Chemotherapy-induced oral mucositis.</hc_freetext>
      <i_freetext>Intervention group: Patients with chemotherapy-induced oral mucositis.  In this before-after clinical trial, the patients were irradiated with a single session of NTCLT. At first, the surgical staff and the patient put on protective eyeglasses. Then, the lesion and its surrounding tissue were covered with a thick layer (3-4 mm) of a non-anesthetic, completely transparent gel containing very high percentage (87.5%) of water (Abzar Darman Co., Iran).  (This gel is routinely used for gastrointestinal endoscopy as a lubricating agent, sonography, etc.) Before the initiation of laser irradiation, the patient and surgical staff put on appropriate safety goggles. The CO2 laser (wavelength: 10600 nm; Lancet-2, Russia) beam (power: 1 Watt, in continuous mode) was irradiated through the gel layer. The lesion was scanned with rapid circular motion of the handpiece over the lesion, while the distance of the tip of the defocused handpiece from the surface of the gel was about 5-6 mm. The laser beam was illuminated to a circle area of the lesion (with a diameter of approximately 1cm) for 5 seconds in each pass. If the contact pain of the lesion persisted, the procedure was repeated again. The gel layer was gently wiped between the passes, and a new layer of gel was placed on the lesion..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Data Privacy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nasrin Zand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Nazari St., Palestine St., Enqelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1315795611</zip>
        <telephone>+98 21 6649 4649</telephone>
        <email>zand_nas@yahoo.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nasrin Zand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Nazari St., Palestine St., Enqelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1315795611</zip>
        <telephone>+98 21 6649 4649</telephone>
        <email>zand_nas@yahoo.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chemotherapy-induced oral mucositis with grade 1-4 according to the WHO classification index
The minimum literacy to read and write and filling the forms
Providing written informed consent after the physician's explanation about the treatment method</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Breastfeeding
History of Photo sensitivity  or use of photo sensitizing drugs
Head and neck radiotherapy
Taking narcotic painkillers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis (ulcerative) due to antineoplastic therapy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with chemotherapy-induced oral mucositis.  In this before-after clinical trial, the patients were irradiated with a single session of NTCLT. At first, the surgical staff and the patient put on protective eyeglasses. Then, the lesion and its surrounding tissue were covered with a thick layer (3-4 mm) of a non-anesthetic, completely transparent gel containing very high percentage (87.5%) of water (Abzar Darman Co., Iran).  (This gel is routinely used for gastrointestinal endoscopy as a lubricating agent, sonography, etc.) Before the initiation of laser irradiation, the patient and surgical staff put on appropriate safety goggles. The CO2 laser (wavelength: 10600 nm; Lancet-2, Russia) beam (power: 1 Watt, in continuous mode) was irradiated through the gel layer. The lesion was scanned with rapid circular motion of the handpiece over the lesion, while the distance of the tip of the defocused handpiece from the surface of the gel was about 5-6 mm. The laser beam was illuminated to a circle area of the lesion (with a diameter of approximately 1cm) for 5 seconds in each pass. If the contact pain of the lesion persisted, the procedure was repeated again. The gel layer was gently wiped between the passes, and a new layer of gel was placed on the lesion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Non-contact (Non-stimulate) pain score. Timepoint: before laser irradiation, immediately after laser irradiation, 4 hours, 8 hours after laser irradiation and then daily until the seventh day. Method of measurement: (Visual analogue scale) VAS.</prim_outcome>
      <prim_outcome>Contact pain score. Timepoint: before laser irradiation, immediately after laser irradiation, 4 hours, 8 hours after laser irradiation and then daily until the seventh day. Method of measurement: (Visual analogue scale) VAS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran National Science Foundation (INSF)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-13</approval_date>
        <contact_name>Ethics committee of Royan Institute</contact_name>
        <contact_address>No 15. Royan Alley, East Hafez St., end of North Bani Hashem St.,  Shahid Soleimani Highway (Resalat), Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
