<?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>IRCT20170211032494N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the tolerability of a diet containing CAPRIDIN in patients with rectal cancer</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the tolerability of the diet containing CAPRIDIN in patients with rectal cancer undergoing chemoradiotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70747</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: "Random Allocation V.2" software is used for randomization. This software can be downloaded from the following link:
 https://random-allocation-software.software.informer.com  
Patients will be allocated in two intervention and control groups in equal numbers.
For randomization, the block randomization method was used, which defines blocks of four, and the order of assigning houses to each group is based on random numbers, Blinding description: Patients and their companions, all the people who are involved in patient registration, doctors, nurses and anyone who is in contact with the patient in the process of treatment and care, and the research team are all kept blind to the prescription and consumption of capridin or placebo. The order of the patient's entry is recorded on the envelopes with the patient's code. Codes are also recorded on bottles containing capridin. After the patient has been examined by the doctor in terms of the criteria for entering the study, according to the order of referral, the desired envelope is opened and the code related to the intervention is determined. Based on the code, the bottle of the same code (capridine or placebo) is given to the patient. In this way, the patient is unaware that he is receiving capridine or a placebo.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Rectal cancer, Ketogenic regimen.</hc_freetext>
      <i_freetext>Intervention 1: Patients who take 30 cc of CAPRIDIN fasting on average for 6 weeks in addition to the standard rectal cancer treatment. Capridin is a product of HealthWeX (Canada) that contains medium chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Treatments based on ketogenesis in the control of epilepsy are among the approved treatments for this disease. Intervention 2: Patients who take 30 cc of placebo daily on an average for 6 weeks in addition to the standard rectal cancer treatment.</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 "No more information has not been provided yet"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhaneh Bayani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8679</telephone>
        <email>r.bayani@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima Mousavi Darzikolaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8679</telephone>
        <email>mousavi-n@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18 to 75 years old
Patients with definitive diagnosis of rectal adenocarcinoma according to histopathology
Patients with a Karnofsky score higher than 70
Non-metastatic patients
Locally advanced patients (T3, T4) N0 or N+
Patients with BMI between 18-34</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with metabolic diseases
Pregnancy
Liver or kidney dysfunction
Receiving neoadjuvant chemotherapy
Patients who have undergone rectal cancer surgery for any reason
Breastfeeding
No previous ketogenic diet</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of rectum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients who take 30 cc of CAPRIDIN fasting on average for 6 weeks in addition to the standard rectal cancer treatment. Capridin is a product of HealthWeX (Canada) that contains medium chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Treatments based on ketogenesis in the control of epilepsy are among the approved treatments for this disease.</i_keyword>
      <i_keyword>Patients who take 30 cc of placebo daily on an average for 6 weeks in addition to the standard rectal cancer treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tolerability: not interrupting the ketogenic diet for more than 4 consecutive days or 8 non-consecutive days. Timepoint: Every four days for 6 weeks. Method of measurement: Medical history taking.</prim_outcome>
      <prim_outcome>Complications: reports of gastrointestinal discomfort, nausea, vomiting, lethargy, constipation, diarrhea by the patient. Timepoint: Every week for 6 weeks. Method of measurement: Medical history taking.</prim_outcome>
      <prim_outcome>Serum ketones: the amount of ketones released in the blood. Timepoint: Before starting the study and every day for 6 weeks. Method of measurement: ketometery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical response: T, N stage based on MRI. Timepoint: 6 weeks after the end of radiotherapy. Method of measurement: Doing pelvic MRI.</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>2022-12-20</approval_date>
        <contact_name>Working Group/Ethics Committee in Research of Imam Khomeini Hospital Complex, Tehran University of M</contact_name>
        <contact_address>Imam Khomeini hospital complex; Qarib Ave; Keshavarz Blvd; Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
