<?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>IRCT201307165665N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-15</date_registration>
      <primary_sponsor>Nursing and Midwifery Faculty- Vice chancellor for research</primary_sponsor>
      <public_title>Effect of Oral Cryotherapy  and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Blood Stem-Cell Transplantation</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Oral Cryotherapy  and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Autologous Blood Stem-Cell Transplantation: A Randomized clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>oral mucositis.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group (ice-therapy) the small ice pieces will prepare in plastic freezer disposable formats (casts) with ready clean mineral water in dedicated refrigerator of each patient. During chemotherapy process, for cooling the oral cavity, the ice chips will place in mouth by the nurse, from 5 minutes before, during and 5 minutes after each intravenous administration of chemotherapy period continuously (mean time 20-40 Min) with considering his tolerance and with 20 minutes interval resting. The ice therapy maintains will continue based chemotherapy protocol. As the ice pieces melts it will replace with new ones. The ice pieces will prepare in a manner that would not irritate the oral cavity and could easily move in the mouth (size approximately 3*4 cm casts) will be provided in sterile containers to patients. If the participants have the prosthetic teeth, they will be asked to remove it. The usual oral care will continue after stem cell transplantation. Intervention 2: In saline rinse group, the participants will be asked to rinse their mouth by a saline solution with the room temperature (23-29 centigrade degree), 30 minutes before chemotherapy to 6 hours after it, every 30 minutes by the nurse. In this way 30-50 ml of normal saline will be used in every time. The usual oral care will continue after transplantation of stem cells.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Askarifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Stem-Cell transplantation unit- Namazi Hospital- Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>marzieh.askarifar@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Lakdizaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5137947977- Nursing and Midwifery Faculty- Shariati Jnoobi Ave.- Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>laks@tbzmed.ac.ir      sima.lak90@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Consciousness; Age between 18 to 70 years; To have Hodgkin's, non Hodgkin's lymphoma or Multiple Myeloma with the same grades; To have healthy oral mucous; Isolation of participants from the beginning of the project; To have Similar Chemotherapy properties; To have the same Autologous transplantation protocols&#13;
Exclusion criteria: Participants’ dissatisfaction; Loss of consciousness; Suffering from other diseases during treatment;  use of narcotic analgesics continuously before the study; Combined therapies such as radiation therapy at the time of study; Fever, neutropenia and mucositis before starting treatment; To have respiratory diseases such as asthma and oral infections; Systemic diseases effective on oral tissues, especially periodontal disease; To have chemotherapy two weeks before transplantation; Change in treatment protocol during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>oral mucositis-ulcerative</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group (ice-therapy) the small ice pieces will prepare in plastic freezer disposable formats (casts) with ready clean mineral water in dedicated refrigerator of each patient. During chemotherapy process, for cooling the oral cavity, the ice chips will place in mouth by the nurse, from 5 minutes before, during and 5 minutes after each intravenous administration of chemotherapy period continuously (mean time 20-40 Min) with considering his tolerance and with 20 minutes interval resting. The ice therapy maintains will continue based chemotherapy protocol. As the ice pieces melts it will replace with new ones. The ice pieces will prepare in a manner that would not irritate the oral cavity and could easily move in the mouth (size approximately 3*4 cm casts) will be provided in sterile containers to patients. If the participants have the prosthetic teeth, they will be asked to remove it. The usual oral care will continue after stem cell transplantation.</i_keyword>
      <i_keyword>In saline rinse group, the participants will be asked to rinse their mouth by a saline solution with the room temperature (23-29 centigrade degree), 30 minutes before chemotherapy to 6 hours after it, every 30 minutes by the nurse. In this way 30-50 ml of normal saline will be used in every time. The usual oral care will continue after transplantation of stem cells.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral Mucositis. Timepoint: before chemotherapy and 3rd, 7th, 14th and21th days folowing end of chemotherapy. Method of measurement: WHO Mucositis Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and Vomiting. Timepoint: During 4 days, every day following end of chemotherapy. Method of measurement: checklist.</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>Nursing and Midwifery Faculty- Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-17</approval_date>
        <contact_name>The ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Deputy- Amoozesh building- Tabriz University of Medical Sciences- Daneshgah Ave.- Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
