<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/NCT02241876</url>
  </required_header>
  <id_info>
    <org_study_id>NAC+Cisplatin2014</org_study_id>
    <nct_id>NCT02241876</nct_id>
  </id_info>
  <brief_title>THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS</brief_title>
  <official_title>EVALUATION OF THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS IN HEAD AND NECK CANCER PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <brief_summary>
    <textblock>
      Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as&#xD;
      the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of&#xD;
      cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities&#xD;
      caused mainly by oxidative stress. The objective of this study will be evaluate the use of&#xD;
      n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and&#xD;
      neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial&#xD;
      with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital /&#xD;
      University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin&#xD;
      antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will&#xD;
      be included in this research. They will be studied in 2 groups (n-acetylcysteine and&#xD;
      placebo). All patients will be evaluated in relation to cisplatin induced hematologic and&#xD;
      gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and&#xD;
      cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be&#xD;
      statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated&#xD;
      measures tests (p&lt;0.05.)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0)</measure>
    <time_frame>120 hours</time_frame>
    <description>Hematologic - anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia; Nephrotoxicity - increase of serum creatinine level and reduction of creatinine clearance; Hepatotoxicity - increase of AST, ALT, ALP, GGT, Total Bilirubin levels.&#xD;
The time frame is 120 hours post-dose and 20 days post-dose (each cycle of Chemotherapy)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal Toxicity - Degree of toxicity by CTCAE (version 4.0)</measure>
    <time_frame>1 day</time_frame>
    <description>Nausea, Vomiting and Diarrhea The time frame is on day 1 and up to 120 hours post-dose (each cycle)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>audiometric testing</measure>
    <time_frame>1 day</time_frame>
    <description>audiometric testing for identification of ototoxic hearing loss. The time frame is prior to day 1 and 30 days after treatment completion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nephrotoxicity</measure>
    <time_frame>1 day</time_frame>
    <description>The nephrotoxicity will be evaluated by EDTA-51Cr. The time frame are prior to day 1 and 30 days after treatment completion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>21 days</time_frame>
    <description>Quality of Life by EORTC-QLQ- 30 and EORTC-QLQ-H&amp;N35 questionnaires The time frame are Day, 1, 22, 43, and 21 days after treatment completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular and plasma oxidative stress biomarkers</measure>
    <time_frame>1 day</time_frame>
    <description>Time frame are Before day 1; 120 hours post-dose and 20 days post-dose (each cycle of chemotherapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of anticancer therapy</measure>
    <time_frame>1 day</time_frame>
    <description>The effectiveness of anticancer therapy will be analyzed by Computed Tomography of the head and neck. The time frame are prior to day 1 and 30 days after treatment completion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patients will be treated with placebo as follows: 15 mL (0 mg of drug), once a day, during 7 days in each cycle (2 days before chemotherapy with cisplatin, on the day of chemotherapy and more 4 days after chemotherapy).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N-Acetylcysteine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be treated with n-acetylcysteine as follows: 15 mL (600mg of drug), once a day, during 7 days in each cycle (2 days before chemotherapy with cisplatin, on the day of chemotherapy and more 4 days after chemotherapy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetylcysteine</intervention_name>
    <arm_group_label>N-Acetylcysteine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  head and neck cancer&#xD;
&#xD;
          -  anticancer treatment - cisplatin (80 to 100 mg/m²) plus radiotherapy&#xD;
&#xD;
          -  patients without previous treatment of head and neck cancer (surgery, chemotherapy and&#xD;
             radiotherapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric diseases&#xD;
&#xD;
          -  impossibility of verbal communication&#xD;
&#xD;
          -  without caregivers or companions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>State University of Campinas - UNICAMP, Hospital das Clinicas</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Patricial Moriel</last_name>
      <phone>55 (19) 35218884</phone>
      <email>morielpa@fcm.unicamp.br</email>
    </contact>
    <contact_backup>
      <last_name>Marília B Visacri</last_name>
      <phone>55 (19) 35218884</phone>
      <email>mariberlofa@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Marilia B Visacri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 13, 2014</last_update_submitted>
  <last_update_submitted_qc>September 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Patricia Moriel</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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>


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/NCT02241876
org study id: NAC+Cisplatin2014
nct id: NCT02241876
lead sponsor: 
Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as
      the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of
      cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities
      caused mainly by oxidative stress. The objective of this study will be evaluate the use of
      n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and
      neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial
      with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital /
      University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin
      antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will
      be included in this research. They will be studied in 2 groups (n-acetylcysteine and
      placebo). All patients will be evaluated in relation to cisplatin induced hematologic and
      gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and
      cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be
      statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated
      measures tests (p<0.05.)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0)
time frame: 120 hours
description: Hematologic - anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia; Nephrotoxicity - increase of serum creatinine level and reduction of creatinine clearance; Hepatotoxicity - increase of AST, ALT, ALP, GGT, Total Bilirubin levels.
The time frame is 120 hours post-dose and 20 days post-dose (each cycle of Chemotherapy)
measure: Gastrointestinal Toxicity - Degree of toxicity by CTCAE (version 4.0)
time frame: 1 day
description: Nausea, Vomiting and Diarrhea The time frame is on day 1 and up to 120 hours post-dose (each cycle)
measure: audiometric testing
time frame: 1 day
description: audiometric testing for identification of ototoxic hearing loss. The time frame is prior to day 1 and 30 days after treatment completion
measure: Nephrotoxicity
time frame: 1 day
description: The nephrotoxicity will be evaluated by EDTA-51Cr. The time frame are prior to day 1 and 30 days after treatment completion
measure: Quality of Life
time frame: 21 days
description: Quality of Life by EORTC-QLQ- 30 and EORTC-QLQ-H&N35 questionnaires The time frame are Day, 1, 22, 43, and 21 days after treatment completion
measure: Cellular and plasma oxidative stress biomarkers
time frame: 1 day
description: Time frame are Before day 1; 120 hours post-dose and 20 days post-dose (each cycle of chemotherapy)
measure: Effectiveness of anticancer therapy
time frame: 1 day
description: The effectiveness of anticancer therapy will be analyzed by Computed Tomography of the head and neck. The time frame are prior to day 1 and 30 days after treatment completion
arm group label: Placebo
arm group type: Placebo Comparator
description: The patients will be treated with placebo as follows: 15 mL (0 mg of drug), once a day, during 7 days in each cycle (2 days before chemotherapy with cisplatin, on the day of chemotherapy and more 4 days after chemotherapy).
arm group label: N-Acetylcysteine
arm group type: Experimental
description: The patients will be treated with n-acetylcysteine as follows: 15 mL (600mg of drug), once a day, during 7 days in each cycle (2 days before chemotherapy with cisplatin, on the day of chemotherapy and more 4 days after chemotherapy).
intervention type: Drug
intervention name: N-acetylcysteine
arm group label: N-Acetylcysteine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Patricia Moriel
investigator title: PhD
mesh term: Head and Neck Neoplasms
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine