<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706627</url>
  </required_header>
  <id_info>
    <org_study_id>MIRCIT</org_study_id>
    <secondary_id>TRF</secondary_id>
    <nct_id>NCT01706627</nct_id>
  </id_info>
  <brief_title>Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial</brief_title>
  <acronym>MIRCIT</acronym>
  <official_title>Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Srinagarind Hospital, Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Khon Kaen Hospital, Khon Kaen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Drugs House Co.,LTD.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thailand Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for&#xD;
      reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo&#xD;
      controlled trials have been conducted. This study evaluates the effect of melatonin in&#xD;
      improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer&#xD;
      patients. This is a multi-center, randomized, double-blind, placebo controlled trial&#xD;
      conducted in patients with histologically proven advanced non small cell lung, breast, head&#xD;
      and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment&#xD;
      scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or&#xD;
      matched placebo. The patients are required to take the studied drugs at night (after 21.00&#xD;
      pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is&#xD;
      chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT),&#xD;
      adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life (FACT)</measure>
    <time_frame>Change from baseline in total scores at 6 months after treatment</time_frame>
    <description>Self-reported questionnaires. FACT-L, FACT-B, FACT-H&amp;N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H&amp;N and FACT-G are used in lung, breast, head&amp;neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Baseline and 1,2,3 and 6 months after treatment</time_frame>
    <description>CTCAE Version 4.3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress status</measure>
    <time_frame>Chemotherapy cycles 1,2,3,4</time_frame>
    <description>8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Melatonin level</measure>
    <time_frame>Chemotherapy cycle 1,2,3 and 4</time_frame>
    <description>Blood, urine and saliva analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Over 4 years of the study</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Advanced Stage Cancer</condition>
  <arm_group>
    <arm_group_label>Matched placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo (identical formulation and delivery, without active ingredient)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: 10 mg Melatonin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg melatonin gelatin capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: 20 mg Melatonin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 mg melatonin gelatin capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg Melatonin</intervention_name>
    <description>Active Comparator: Drug: Melatonin 10 mg</description>
    <arm_group_label>Drug: 10 mg Melatonin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20 mg Melatonin</intervention_name>
    <description>Active Comparator: Drug: Melatonin 20 mg</description>
    <arm_group_label>Drug: 20 mg Melatonin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matched placebo</intervention_name>
    <description>Matched placebo (identical formulation and delivery, without active ingredient)</description>
    <arm_group_label>Matched placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern&#xD;
             Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2&#xD;
&#xD;
          -  platelet count ≥100,000 cells/mm3&#xD;
&#xD;
          -  white blood cell count ≥ 3,000 cell/mm3&#xD;
&#xD;
          -  hemoglobin ≥ 10 g/dL&#xD;
&#xD;
          -  serum creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
          -  bilirubin ≤ 2 mg/dL&#xD;
&#xD;
          -  AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5&#xD;
             times UNL for those with liver metastases&#xD;
&#xD;
          -  New York Heart Association grade ≤ 2&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within&#xD;
             1 month preceding randomization&#xD;
&#xD;
          -  Patients who have more than one type of cancer or brain metastasis were excluded from&#xD;
             the trial.&#xD;
&#xD;
          -  Patients with moderate neuropathy (CTCAE grade ≥ 2)&#xD;
&#xD;
          -  Patients with an active infection, or uncontrolled complications (i.e. blood glucose &gt;&#xD;
             200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart&#xD;
             failure or history of myocardial infarction within one year).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Khon Kaen Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Srinagarind Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Nutjaree Pratheepawanit Johns</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>melatonin</keyword>
  <keyword>adjuvant therapy</keyword>
  <keyword>quality of life</keyword>
  <keyword>survival</keyword>
  <keyword>adverse events</keyword>
  <keyword>oxidative stress</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706627
org study id: MIRCIT
secondary id: TRF
nct id: NCT01706627
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for
      reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo
      controlled trials have been conducted. This study evaluates the effect of melatonin in
      improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer
      patients. This is a multi-center, randomized, double-blind, placebo controlled trial
      conducted in patients with histologically proven advanced non small cell lung, breast, head
      and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment
      scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or
      matched placebo. The patients are required to take the studied drugs at night (after 21.00
      pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is
      chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT),
      adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Quality of Life (FACT)
time frame: Change from baseline in total scores at 6 months after treatment
description: Self-reported questionnaires. FACT-L, FACT-B, FACT-H&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H&N and FACT-G are used in lung, breast, head&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.
measure: Number of participants with adverse events
time frame: Baseline and 1,2,3 and 6 months after treatment
description: CTCAE Version 4.3
measure: Oxidative stress status
time frame: Chemotherapy cycles 1,2,3,4
description: 8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis
measure: Melatonin level
time frame: Chemotherapy cycle 1,2,3 and 4
description: Blood, urine and saliva analysis
measure: Overall survival
time frame: Over 4 years of the study
description: Overall survival
arm group label: Matched placebo
arm group type: Placebo Comparator
description: Matched placebo (identical formulation and delivery, without active ingredient)
arm group label: Drug: 10 mg Melatonin
arm group type: Active Comparator
description: 10 mg melatonin gelatin capsule
arm group label: Drug: 20 mg Melatonin
arm group type: Active Comparator
description: 20 mg melatonin gelatin capsule
intervention type: Drug
intervention name: 10 mg Melatonin
description: Active Comparator: Drug: Melatonin 10 mg
arm group label: Drug: 10 mg Melatonin
intervention type: Drug
intervention name: 20 mg Melatonin
description: Active Comparator: Drug: Melatonin 20 mg
arm group label: Drug: 20 mg Melatonin
intervention type: Drug
intervention name: Matched placebo
description: Matched placebo (identical formulation and delivery, without active ingredient)
arm group label: Matched placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Nutjaree Pratheepawanit Johns
investigator title: Associate Professor
mesh term: Melatonin