<?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>IRCT20250607066102N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-07</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of henna on preventing chemotherapy-induced neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of henna in preventing neuropathy caused by chemotherapy with taxane drugs in cancer patients treated with chemotherapy regimens</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the random permutation block method will be used for randomization. For this purpose, a block of 6 will be used. In each block, three cards will be written with the letter I (Intervention) and three cards with the letter P (Placebo). To hide the cards, they will be placed in an envelope and turned over several times so that their order is not clear. As each participant enters, a card will be selected for him and the selected card will be set aside. This will be done for the next five patients until 6 people are identified. Then, randomization will be done in the same way for the other groups of 6 people to achieve the desired sample size.
Some of the selected random blocks of 6 are as follows:
PIPIIP, PPIPII, IPPIIP, PIPIPI, IPPIIP, IPIIPP, PIIIPP, IPPIIP, PIIPPI, PPIPII, LPLLPP, LLPLPP, IPPIIP (For example, the random assignment in the 6-patient block PIPIIP is as follows: the first patient is randomly assigned to treatment P, the second patient is randomly assigned to treatment I, the third patient is randomly assigned to treatment P, the fourth patient is randomly assigned to treatment I, the fifth patient is randomly assigned to treatment I, and the sixth patient is randomly assigned to treatment P.).</study_design>
      <phase>3</phase>
      <hc_freetext>Chemotherapy-induced peripheral neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Henna purchased from Atabak Company, Yazd, Iran, is made into 50-gram packets and given to patients, which is mixed with lukewarm water and applied to their hands and feet for 8 hours after each chemotherapy course, which is done every 3 weeks, and 6 chemotherapy courses are done. (Henna is used once every 3 weeks.). Intervention 2: Control group: Do not receive any intervention to reduce chemotherapy-induced peripheral neuropathy.</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 The release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Rahzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>34,Sedaghat Alley, Kishani Alley, Ayatollah Ghaffari ave</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817718734</zip>
        <telephone>+98 86 3328 7413</telephone>
        <email>saharrahzani79@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Razavi Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>34,Sedaghat Alley, Kishani Alley, Ayatollah Ghaffari ave</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817718734</zip>
        <telephone>+98 86 3328 7413</telephone>
        <email>homa.razavi84@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with cancer who receive taxane chemotherapy drugs.
All patients receiving taxanes who are receiving their first course of chemotherapy.
Patients should not have previous proven neuropathy.
Patients should not have proven diabetes.
Patients should not have neurological damage such as Parkinson's, stroke, seizures, etc.
They should not have swelling in their hands or feet.
Do not have open wounds on your hands or feet.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an allergy or allergic reaction to henna
Lack of cooperation from patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G13.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Paraneoplastic neuromyopathy and neuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Henna purchased from Atabak Company, Yazd, Iran, is made into 50-gram packets and given to patients, which is mixed with lukewarm water and applied to their hands and feet for 8 hours after each chemotherapy course, which is done every 3 weeks, and 6 chemotherapy courses are done. (Henna is used once every 3 weeks.)</i_keyword>
      <i_keyword>Control group: Do not receive any intervention to reduce chemotherapy-induced peripheral neuropathy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemotherapy-induced peripheral neuropathy score of European organization for research and treatment of cancer Quality of Live questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) questionnaire. Timepoint: 3 weeks after intervention. Method of measurement: EORTC QLQ-CIPN20 questionnaire.</prim_outcome>
      <prim_outcome>Chemotherapy-induced peripheral neuropathy score from the Neuropathic Pain Symptom Inventory (NPSI) questionnaire. Timepoint: 3 weeks after intervention. Method of measurement: NPSI questionnaire.</prim_outcome>
      <prim_outcome>Chemotherapy-induced peripheral neuropathy score on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) questionnaire. Timepoint: 3 weeks after intervention. Method of measurement: NCI-CTCAE questionnaire.</prim_outcome>
      <prim_outcome>Nerve conduction velocity (NCV). Timepoint: Before the intervention and 3 weeks after the last intervention. Method of measurement: NCV device.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-18</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Basij Square, Sardasht neighborhood, arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
