<?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>IRCT20220208053971N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of oral nutrition supplement (ONS) on autologous hematopoietic stem cell transplantation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of oral nutrition supplement (ONS) on nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66075</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified block randomization will be performed based on the sex and age and using the site www.randomization.com. In this method, each group will be assigned one of the letters A and B, and randomization will be done in blocks with size of 4 . This will be done for sex (male and female) and age (18-35 and 35-50 years old). Within each class, patients will be randomly assigned to one of the two study groups in a 1: 1 ratio. The randomization process will be performed by someone outside the research team.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Lymphoma. Condition 2: multiple myeloma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The type of intervention in the treatment group will be an oral nutritional supplement of 500 kcal, including carbohydrates, fat, protein, vitamins, and minerals. The formula will be given to patients in the amount of 250 ccs in the morning and bedtime snacks. The control group will not receive any supplements. The intervention will be carried out for 21 days and we will follow up with the patients until 90 days after the transplant. Intervention 2: Control group: The control group will not receive any supplements.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the confidentiality of participant information, it is not possible to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hamed Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>0098 21 889900285</telephone>
        <email>mohamadihd@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr, Hamed Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>0098 21 889900285</telephone>
        <email>mohamadihd@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with lymphoma or multiple myeloma are candidates for autologous hematopoietic stem cell transplantation
Age range 18-50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to cooperate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C85.9</hc_code>
      <hc_code>C90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-Hodgkin lymphoma, unspecified</hc_keyword>
      <hc_keyword>Multiple myeloma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The type of intervention in the treatment group will be an oral nutritional supplement of 500 kcal, including carbohydrates, fat, protein, vitamins, and minerals. The formula will be given to patients in the amount of 250 ccs in the morning and bedtime snacks. The control group will not receive any supplements. The intervention will be carried out for 21 days and we will follow up with the patients until 90 days after the transplant.</i_keyword>
      <i_keyword>Control group: The control group will not receive any supplements.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Seca Scales.</prim_outcome>
      <prim_outcome>Body mass index(BMI). Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Questionnaire and calculation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rate of infection during hospitalization. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Recurrence rate after transplantation. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Severity of oral mucositis. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: According to the WHO oral toxicity criteria.</sec_outcome>
      <sec_outcome>Number of readmissions after transplantation during three months. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>The number of days it takes for neutrophil engraftment to occur. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Complete Blood cell Count.</sec_outcome>
      <sec_outcome>The number of days it takes for platelet engraftment to occur. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Complete Blood cell Count.</sec_outcome>
      <sec_outcome>Graft Failure. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Based on medical records.</sec_outcome>
      <sec_outcome>Mortality rate up to three months after transplantation. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Based on medical records.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Visual analog scale.</sec_outcome>
      <sec_outcome>Hand grip strength. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Hand dynamometer.</sec_outcome>
      <sec_outcome>Mid-arm circumference. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Seca tape measure.</sec_outcome>
      <sec_outcome>Calf circumference. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Seca tape measure.</sec_outcome>
      <sec_outcome>Total energy intake. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Food record questionnaire &amp; Analysis by N4 software.</sec_outcome>
      <sec_outcome>Protein intake. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Food record questionnaire &amp; Analysis by N4 software.</sec_outcome>
      <sec_outcome>Carbohydrate intake. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: food record questionnaire &amp; Analysis by N4 software.</sec_outcome>
      <sec_outcome>Fat intake. Timepoint: The first stage, on the negative day 7 of transplantation, the second stage, positive 14 days after transplantation, and the third stage, 90 days after transplantation. Method of measurement: Food record questionnaire &amp; Analysis by N4 software.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-28</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical sciences</contact_name>
        <contact_address>Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
