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/NCT06019520</url>
    </required_header>
    <id_info>
      <org_study_id>FUI/CTR/2023/14</org_study_id>
      <nct_id>NCT06019520</nct_id>
    </id_info>
    <brief_title>Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity</brief_title>
    <official_title>Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Foundation University Islamabad</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Foundation University Islamabad</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer,&#xD;
        head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial&#xD;
        cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe&#xD;
        nephrotoxicity, which particularly affects the proximal tubule epithelial cells&#xD;
        (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity,&#xD;
        although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing&#xD;
        antioxidant, which not only acts as a precursor of glutathione but also as a direct&#xD;
        antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a&#xD;
        low-cost, easily available drug with a very good safety profile and therefore can be added as&#xD;
        a support medication during treatment with cisplatin. The investigators plan to administer&#xD;
        1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6&#xD;
        days, with an objective to ascertain its nephroprotective role in population receiving&#xD;
        Cisplatin/-based chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">March 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 9, 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>
      <intervention_model_description>It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum creatinine of participant</measure>
      <time_frame>18 weeks</time_frame>
      <description>Blood samples collected and measured in laboratory with the unit mg/dL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Creatinine clearance of participant</measure>
      <time_frame>18 weeks</time_frame>
      <description>It will be calculated using Cockroft-Gault formula , unit ml/min</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Estimation of Acute kidney injury to participant</measure>
      <time_frame>18 weeks</time_frame>
      <description>Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood urea nitrogen of participant</measure>
      <time_frame>18 weeks</time_frame>
      <description>Blood samples collected and measured in laboratory with the unit mg/dl</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Drug Toxicity</condition>
    <arm_group>
      <arm_group_label>Cisplatin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>N-acetylcysteine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N-Acetylcysteine</intervention_name>
      <description>Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy.</description>
      <arm_group_label>N-acetylcysteine group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chemotherapy</intervention_name>
      <description>Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.</description>
      <arm_group_label>Cisplatin group</arm_group_label>
      <arm_group_label>N-acetylcysteine group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult female outpatients with non-hematological malignancies (Breast, ovary and head&#xD;
               and neck squamous cell carcinomas)&#xD;
  &#xD;
            -  Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never&#xD;
               received platinum based Chemotherapy in past and were now scheduled to receive&#xD;
               high-dose cisplatin chemotherapy.&#xD;
  &#xD;
            -  Patients were required to have estimated glomerular filtration rate (GFR)(according to&#xD;
               Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal&#xD;
               Blood Counts, Liver, and kidney function tests&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had poor performance status i.e., ECOG Performance Status 3 or 4&#xD;
  &#xD;
            -  Who declined to participate at any time during the course of the study&#xD;
  &#xD;
            -  Patients having hepatic failure (Liver Function tests &gt;3 times of upper limit normal)&#xD;
  &#xD;
            -  Patients who did not tolerate the use of NAC or were administered the drug &lt;70% of the&#xD;
               time&#xD;
  &#xD;
            -  Patient who were receiving concurrent nephrotoxic drugs, or having history of&#xD;
               Hypersensitivity to N-Acetyl cysteine.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The study includes adult female outpatients with non-hematological malignancies</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medical Oncology department, Fauji Foundation Hospital</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>46000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Drug-Related Side Effects and Adverse Reactions</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetylcysteine</mesh_term>
      <mesh_term>N-monoacetylcystine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06019520
  org study id: FUI/CTR/2023/14
  nct id: NCT06019520
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer,
        head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial
        cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe
        nephrotoxicity, which particularly affects the proximal tubule epithelial cells
        (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity,
        although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing
        antioxidant, which not only acts as a precursor of glutathione but also as a direct
        antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a
        low-cost, easily available drug with a very good safety profile and therefore can be added as
        a support medication during treatment with cisplatin. The investigators plan to administer
        1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6
        days, with an objective to ascertain its nephroprotective role in population receiving
        Cisplatin/-based chemotherapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Serum creatinine of participant
  time frame: 18 weeks
  description: Blood samples collected and measured in laboratory with the unit mg/dL
  measure: Creatinine clearance of participant
  time frame: 18 weeks
  description: It will be calculated using Cockroft-Gault formula , unit ml/min
  measure: Estimation of Acute kidney injury to participant
  time frame: 18 weeks
  description: Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients
  measure: Blood urea nitrogen of participant
  time frame: 18 weeks
  description: Blood samples collected and measured in laboratory with the unit mg/dl
  arm group label: Cisplatin group
  arm group type: Active Comparator
  description: This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol
  arm group label: N-acetylcysteine group
  arm group type: Experimental
  description: Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.
  intervention type: Drug
  intervention name: N-Acetylcysteine
  description: Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy.
  arm group label: N-acetylcysteine group
  intervention type: Drug
  intervention name: Chemotherapy
  description: Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.
  arm group label: Cisplatin group
  arm group label: N-acetylcysteine group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The study includes adult female outpatients with non-hematological malignancies
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Drug-Related Side Effects and Adverse Reactions
  mesh term: Acetylcysteine
  mesh term: N-monoacetylcystine