<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/NCT04430361</url>
  </required_header>
  <id_info>
    <org_study_id>2017098</org_study_id>
    <nct_id>NCT04430361</nct_id>
  </id_info>
  <brief_title>the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy</brief_title>
  <official_title>Comparison of the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: a Prospective, Randomized Controlled Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henan Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henan Cancer Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy and safety of megestrol acetate dispersible tablets combined with&#xD;
      5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor&#xD;
      antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by&#xD;
      hyperemetic chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      120 patients with malignant tumors diagnosed by pathology or cytology and treated with highly&#xD;
      emetogenic chemotherapy drugs containing cisplatin from September 2018 to December 2019 were&#xD;
      selected. The patients were randomly assigned to megestrol group (megestrol acetate&#xD;
      dispersible tablets+5-HT3 receptor antagonist+dexamethasone) or control group (5-HT3 receptor&#xD;
      antagonist + dexamethasone) at 1:1. The dosage of antiemetic drugs in the control group:&#xD;
      5-HT3 receptor antagonist 2.5mg, dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,&#xD;
      all were injected intravenously with 30min before chemotherapy for 5 days. The patients in&#xD;
      the megestrol acetate group were given megestrol acetate dispersible tablets on the basis of&#xD;
      the control group. 160 mg of megestrol acetate dispersible tablets were taken orally every&#xD;
      morning on the day of the beginning of chemotherapy for 10 days. The main end point was the&#xD;
      proportion of control of nausea and vomiting between the two groups during the delayed period&#xD;
      (24-120 hours after the beginning of chemotherapy), that is, the proportion of complete&#xD;
      remission (no vomiting and no need for rescue treatment) and complete prevention (no nausea&#xD;
      and vomiting).The secondary end point was the control ratio of nausea and vomiting in the&#xD;
      acute phase (0-24 hours after the beginning of chemotherapy) and the overall phase (0-120&#xD;
      hours after the beginning of chemotherapy); the proportion of patients with grade 3-4 nausea&#xD;
      and vomiting during chemotherapy; the adverse reactions related to antiemetic drugs and the&#xD;
      score of quality of life of patients in both groups before and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 7, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 2</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>The proportion of control of nausea and vomiting between the two groups during the delayed period</measure>
    <time_frame>24 to120 hours</time_frame>
    <description>The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period chemotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The control ratio of nausea and vomiting in the acute phase and the overall phase</measure>
    <time_frame>0 to 120 hours</time_frame>
    <description>The control ratio of nausea and vomiting in the acute phase and the overall phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with grade 3-4 vomiting</measure>
    <time_frame>0 to 120 hours</time_frame>
    <description>The proportion of patients with grade 3-4 vomiting during chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adverse reactions related to antiemetic drugs</measure>
    <time_frame>1 mounth</time_frame>
    <description>The adverse reactions related to antiemetic drugs of patients in both groups before and after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The score of quality of life of patients</measure>
    <time_frame>1 mounth</time_frame>
    <description>The score of quality of life of patients in both groups before and after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Tumor</condition>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Megestrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Palonosetron 2.5mg, Dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, Megestrol acetates 160mg orally every morning on the day of the beginning of chemotherapy for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Megestrol</intervention_name>
    <description>160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.</description>
    <arm_group_label>Megestrol</arm_group_label>
    <other_name>Megestrol acetate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-HT3 receptor antagonist</intervention_name>
    <description>5-HT3 receptor antagonist 2.5mg/iv</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Megestrol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone</intervention_name>
    <description>dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Megestrol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tumor patients diagnosed by histopathology or cytology, as long as the chemotherapy&#xD;
             with cisplatin is used, the amount of cisplatin is 60-80 mg/m2;&#xD;
&#xD;
          -  Unlimited gender, age 18 to 70 years old;&#xD;
&#xD;
          -  ECOG physical status score 0-1;&#xD;
&#xD;
          -  The survival time is predicted to be more than 3 months;&#xD;
&#xD;
          -  Bone marrow hematopoietic function was not significantly impaired (WBC≥3.5109/L,&#xD;
             ANC≥1.5109/L, PLT≥100109/L, Hb≥100g/L);&#xD;
&#xD;
          -  Biochemical examination AST / ALT ≤ 2.5 times the upper limit of normal; bilirubin ≤&#xD;
             1.5 times the upper limit of normal; creatinine clearance ≥ 60ml / min, normal ECG;&#xD;
&#xD;
          -  Signing informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding, women of childbearing age who refuse to&#xD;
             receive contraception;&#xD;
&#xD;
          -  Brain metastasis;&#xD;
&#xD;
          -  Combine all of the following serious or uncontrolled diseases that affect&#xD;
             participation in the trial: Uncontrollable hypertension, history of unstable&#xD;
             hypertension, or poor adherence to antihypertention drugs; Unstable angina;&#xD;
             Symptomatic congestive heart failure; Myocardial infarction occurred within 6 months&#xD;
             before enrollment; Severe uncontrollable arrhythmia; Uncontrollable diabetes; Active&#xD;
             or uncontrollable infection; Intestinal paralysis, intestinal obstruction,&#xD;
             interstitial pneumonia, active gastric ulcer; Subject to immunosuppressive therapy;&#xD;
&#xD;
          -  Inability to understand or express informed consent;&#xD;
&#xD;
          -  The investigator judged other conditions that were not suitable for clinical research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suxia Luo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ning Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ning Li</last_name>
    <phone>13526501903</phone>
    <email>lining97@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ning Li</last_name>
      <phone>13526501903</phone>
      <email>lining97@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Megestrol</keyword>
  <keyword>Tumor</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Chemotherapy-induced nausea and vomiting</keyword>
  <keyword>Highly emetogenic chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Megestrol</mesh_term>
    <mesh_term>Megestrol Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04430361
org study id: 2017098
nct id: NCT04430361
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy and safety of megestrol acetate dispersible tablets combined with
      5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor
      antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by
      hyperemetic chemotherapy.
120 patients with malignant tumors diagnosed by pathology or cytology and treated with highly
      emetogenic chemotherapy drugs containing cisplatin from September 2018 to December 2019 were
      selected. The patients were randomly assigned to megestrol group (megestrol acetate
      dispersible tablets+5-HT3 receptor antagonist+dexamethasone) or control group (5-HT3 receptor
      antagonist + dexamethasone) at 1:1. The dosage of antiemetic drugs in the control group:
      5-HT3 receptor antagonist 2.5mg, dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,
      all were injected intravenously with 30min before chemotherapy for 5 days. The patients in
      the megestrol acetate group were given megestrol acetate dispersible tablets on the basis of
      the control group. 160 mg of megestrol acetate dispersible tablets were taken orally every
      morning on the day of the beginning of chemotherapy for 10 days. The main end point was the
      proportion of control of nausea and vomiting between the two groups during the delayed period
      (24-120 hours after the beginning of chemotherapy), that is, the proportion of complete
      remission (no vomiting and no need for rescue treatment) and complete prevention (no nausea
      and vomiting).The secondary end point was the control ratio of nausea and vomiting in the
      acute phase (0-24 hours after the beginning of chemotherapy) and the overall phase (0-120
      hours after the beginning of chemotherapy); the proportion of patients with grade 3-4 nausea
      and vomiting during chemotherapy; the adverse reactions related to antiemetic drugs and the
      score of quality of life of patients in both groups before and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of control of nausea and vomiting between the two groups during the delayed period
time frame: 24 to120 hours
description: The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period chemotherapy
measure: The control ratio of nausea and vomiting in the acute phase and the overall phase
time frame: 0 to 120 hours
description: The control ratio of nausea and vomiting in the acute phase and the overall phase
measure: The proportion of patients with grade 3-4 vomiting
time frame: 0 to 120 hours
description: The proportion of patients with grade 3-4 vomiting during chemotherapy
measure: The adverse reactions related to antiemetic drugs
time frame: 1 mounth
description: The adverse reactions related to antiemetic drugs of patients in both groups before and after treatment.
measure: The score of quality of life of patients
time frame: 1 mounth
description: The score of quality of life of patients in both groups before and after treatment.
arm group label: Megestrol
arm group type: Experimental
description: Palonosetron 2.5mg, Dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, Megestrol acetates 160mg orally every morning on the day of the beginning of chemotherapy for 10 days.
arm group label: Control
arm group type: Other
description: Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day
intervention type: Drug
intervention name: Megestrol
description: 160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.
arm group label: Megestrol
other name: Megestrol acetate
intervention type: Drug
intervention name: 5-HT3 receptor antagonist
description: 5-HT3 receptor antagonist 2.5mg/iv
arm group label: Control
arm group label: Megestrol
intervention type: Drug
intervention name: dexamethasone
description: dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,
arm group label: Control
arm group label: Megestrol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suxia Luo
role: Principal Investigator
affiliation: Henan Cancer Hospital
last name: Ning Li
role: Principal Investigator
affiliation: Henan Cancer Hospital
last name: Ning Li
phone: 13526501903
email: lining97@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Dexamethasone
mesh term: Megestrol
mesh term: Megestrol Acetate
sharing ipd: No