xml: <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/NCT06039280</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-HCC-06</org_study_id>
      <nct_id>NCT06039280</nct_id>
    </id_info>
    <brief_title>Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.</brief_title>
    <official_title>Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization - Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        N-acetylcysteine (NAC), a glutathione precursor and potent antioxidant, is known as a liver&#xD;
        protector. As a steroid preparation, dexamethasone is known to have efficient&#xD;
        anti-inflammation and immunosuppression effects. N-acetyl cysteine and Dexamethasone's roles&#xD;
        in preventing post-embolization syndrome following TACE have each been researched&#xD;
        individually in the past. Up until now, no study has been done that has compared&#xD;
        dexamethasone and NAC in post-embolization syndrome. With this study, we aim to study the&#xD;
        efficacy of combining dexamethasone with N-acetyl cysteine in the prevention of&#xD;
        post-embolization syndrome within 72 hours among patients who undergo transarterial&#xD;
        chemoembolization for HCC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim &amp; Objectives Hypothesis: The combination of dexamethasone with NAC is superior to NAC&#xD;
        alone in prevention of PES among patients who undergo TACE in HCC as both medications work&#xD;
        differently to prevent PES.&#xD;
  &#xD;
        AIM:- To study the efficacy of combining Dexamethasone to N acetyl cysteine in prevention of&#xD;
        post embolization syndrome within 72 hours among patients who undergo transarterial&#xD;
        chemoembolization for HCC.&#xD;
  &#xD;
        Objective - PRIMARY Prevention of post embolisation syndrome within 72 hours.&#xD;
  &#xD;
        SECONDARY&#xD;
  &#xD;
          -  Prevention of post embolisation decompensation at 2 weeks.&#xD;
  &#xD;
          -  Decrease in the duration of hospitalization.&#xD;
  &#xD;
          -  To study the adverse effects of NAC and steroids in patients who undergo transarterial&#xD;
             chemoembolisation for HCC.&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
          -  All patients undergoing TACE procedure&#xD;
  &#xD;
          -  Valid Consent&#xD;
  &#xD;
          -  Age 18-65 years&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        Monocentric open label prospective randomized controlled study. The study will be conducted&#xD;
        in Department of Hepatology, ILBS.&#xD;
  &#xD;
        Sample size:&#xD;
  &#xD;
          -  Assuming that NAC prevents PES by 75% and addition of dexamethasone further prevents PES&#xD;
             by 20 % (i.e combination of NAC and Dexamethasone prevents total 95%).&#xD;
  &#xD;
          -  Then with alpha as 5% and power 90 % .we need to enroll total 130 cases i.e 65 in each&#xD;
             arm.&#xD;
  &#xD;
          -  Further assuming 10% drop out , it is decided to enroll 150 cases i.e. 75 in each arm.&#xD;
  &#xD;
          -  Allocation will be done randomly by block randomization method, taking block size as 10.&#xD;
  &#xD;
        Monitoring and assessment: All the parameters of the objective and also noted any adverse&#xD;
        effects.&#xD;
  &#xD;
        Intervention: TACE.&#xD;
  &#xD;
        STATISTICAL ANALYSIS:&#xD;
  &#xD;
        The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The&#xD;
        categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous&#xD;
        data will be compiled using t-test. Besides this the univariate and multivariate survival&#xD;
        analysis will be carried out using Cox regression method. Kaplan-Meier technique will be&#xD;
        applied for further analysis. P-value&lt;0.05 will be considered as significant.&#xD;
  &#xD;
        Adverse effects: allergic drug reaction.&#xD;
  &#xD;
        Stopping rule: If patient decided to withdraw from study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Prevention of post-embolization syndrome</measure>
      <time_frame>72 hours</time_frame>
      <description>Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevention of post TACE decompensation at 4 weeks</measure>
      <time_frame>4 weeks</time_frame>
      <description>Metric / Method of measurement : Post TACE decompensation defined as an increase in Child-Pugh score of more than two points or newly developed decompensating events, such as ascites, hepatic encephalopathy, or serum total bilirubin &gt; 2 mg/dL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decrease in the duration of hospitalisation</measure>
      <time_frame>4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC</measure>
      <time_frame>2 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>NAC+Dexamethasone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.&#xD;
  Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NAC+Placebo</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N Acetylcysteine</intervention_name>
      <description>NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.</description>
      <arm_group_label>NAC+Dexamethasone</arm_group_label>
      <arm_group_label>NAC+Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.</description>
      <arm_group_label>NAC+Dexamethasone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The placebo will be administered in the same way as the drug in the experimental group.</description>
      <arm_group_label>NAC+Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients undergoing TACE procedure&#xD;
  &#xD;
            -  Valid Consent&#xD;
  &#xD;
            -  Age 18-65 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Child Pugh C, Child Pugh B &gt; 8&#xD;
  &#xD;
            -  HCC patients with a curative therapy (Ablation, Resection or LT)&#xD;
  &#xD;
            -  ECOG Performance Status 3-4&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  History of allergic reaction from NAC&#xD;
  &#xD;
            -  significant cardiopulmonary disease&#xD;
  &#xD;
            -  UGI bleed within last 28 days&#xD;
  &#xD;
            -  Recent surgery within last 28 days&#xD;
  &#xD;
            -  Documented febrile illness in last 1 weeks&#xD;
  &#xD;
            -  Uncontrolled Diabetes (FBS &gt; 200, HBA1C &gt; 8)&#xD;
  &#xD;
            -  Uncontrolled Hypertension (BP &gt; 160/100)&#xD;
  &#xD;
            -  Structural kidney disease with eGFR &lt; 60 ml/min&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr Phool Chand, MD</last_name>
      <phone>01146300000</phone>
      <email>phoolchand99@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Phool Chand, MD</last_name>
        <phone>01146300000</phone>
        <email>phoolchand99@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetylcysteine</mesh_term>
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>N-monoacetylcystine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039280
  org study id: ILBS-HCC-06
  nct id: NCT06039280
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  N-acetylcysteine (NAC), a glutathione precursor and potent antioxidant, is known as a liver
        protector. As a steroid preparation, dexamethasone is known to have efficient
        anti-inflammation and immunosuppression effects. N-acetyl cysteine and Dexamethasone's roles
        in preventing post-embolization syndrome following TACE have each been researched
        individually in the past. Up until now, no study has been done that has compared
        dexamethasone and NAC in post-embolization syndrome. With this study, we aim to study the
        efficacy of combining dexamethasone with N-acetyl cysteine in the prevention of
        post-embolization syndrome within 72 hours among patients who undergo transarterial
        chemoembolization for HCC.
  Aim & Objectives Hypothesis: The combination of dexamethasone with NAC is superior to NAC
        alone in prevention of PES among patients who undergo TACE in HCC as both medications work
        differently to prevent PES.
  
        AIM:- To study the efficacy of combining Dexamethasone to N acetyl cysteine in prevention of
        post embolization syndrome within 72 hours among patients who undergo transarterial
        chemoembolization for HCC.
  
        Objective - PRIMARY Prevention of post embolisation syndrome within 72 hours.
  
        SECONDARY
  
          -  Prevention of post embolisation decompensation at 2 weeks.
  
          -  Decrease in the duration of hospitalization.
  
          -  To study the adverse effects of NAC and steroids in patients who undergo transarterial
             chemoembolisation for HCC.
  
        Methodology:
  
        Study population:
  
          -  All patients undergoing TACE procedure
  
          -  Valid Consent
  
          -  Age 18-65 years
  
        Study design:
  
        Monocentric open label prospective randomized controlled study. The study will be conducted
        in Department of Hepatology, ILBS.
  
        Sample size:
  
          -  Assuming that NAC prevents PES by 75% and addition of dexamethasone further prevents PES
             by 20 % (i.e combination of NAC and Dexamethasone prevents total 95%).
  
          -  Then with alpha as 5% and power 90 % .we need to enroll total 130 cases i.e 65 in each
             arm.
  
          -  Further assuming 10% drop out , it is decided to enroll 150 cases i.e. 75 in each arm.
  
          -  Allocation will be done randomly by block randomization method, taking block size as 10.
  
        Monitoring and assessment: All the parameters of the objective and also noted any adverse
        effects.
  
        Intervention: TACE.
  
        STATISTICAL ANALYSIS:
  
        The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The
        categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous
        data will be compiled using t-test. Besides this the univariate and multivariate survival
        analysis will be carried out using Cox regression method. Kaplan-Meier technique will be
        applied for further analysis. P-value<0.05 will be considered as significant.
  
        Adverse effects: allergic drug reaction.
  
        Stopping rule: If patient decided to withdraw from study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Prevention of post-embolization syndrome
  time frame: 72 hours
  description: Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score
  measure: Prevention of post TACE decompensation at 4 weeks
  time frame: 4 weeks
  description: Metric / Method of measurement : Post TACE decompensation defined as an increase in Child-Pugh score of more than two points or newly developed decompensating events, such as ascites, hepatic encephalopathy, or serum total bilirubin > 2 mg/dL.
  measure: Decrease in the duration of hospitalisation
  time frame: 4 weeks
  measure: Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC
  time frame: 2 weeks
  arm group label: NAC+Dexamethasone
  arm group type: Experimental
  description: NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
  Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.
  arm group label: NAC+Placebo
  arm group type: Active Comparator
  description: NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
  intervention type: Drug
  intervention name: N Acetylcysteine
  description: NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
  arm group label: NAC+Dexamethasone
  arm group label: NAC+Placebo
  intervention type: Drug
  intervention name: Dexamethasone
  description: Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.
  arm group label: NAC+Dexamethasone
  intervention type: Other
  intervention name: Placebo
  description: The placebo will be administered in the same way as the drug in the experimental group.
  arm group label: NAC+Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Dr Phool Chand, MD
  phone: 01146300000
  email: phoolchand99@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Acetylcysteine
  mesh term: Dexamethasone
  mesh term: N-monoacetylcystine
  sharing ipd: No