<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/NCT03778281</url>
  </required_header>
  <id_info>
    <org_study_id>HL002</org_study_id>
    <nct_id>NCT03778281</nct_id>
  </id_info>
  <brief_title>Treatment of Chemotherapy-related Hiccups With Baclofen</brief_title>
  <official_title>Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Nanchang University</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>
      Hiccup is one of the common side effects of chemotherapy. Intractable hiccups seriously&#xD;
      affect patients' rest and eating, reduce the quality of life, and increasingly attract the&#xD;
      attention of oncologists. At present, drugs or methods for treating chemotherapy-related&#xD;
      hiccups are generally ineffective, with short remission time, serious adverse reactions, and&#xD;
      unsatisfactory clinical effects. Baclofen produces skeletal muscle relaxation and was&#xD;
      originally used in patients with spinal cord injury, and has since been used to treat&#xD;
      intractable hiccups caused by diaphragmatic spasm. This study was an open-label, randomized,&#xD;
      prospective study comparing the efficacy and adverse effects of baclofen versus&#xD;
      metoclopramide in the treatment of chemotherapy-related hiccups. Patients with hiccup after&#xD;
      chemotherapy were randomly divided into two groups. One group was treated with baclofen and&#xD;
      the other group was treated with metoclopramide. The efficacy and adverse reactions of the&#xD;
      two groups were compared.Ineffective in the two groups will cross to another group and then&#xD;
      observe the efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hiccup is due to paroxysmal paralysis of the diaphragm, sudden inhalation of gas accompanied&#xD;
      by rapid glottis closure and a short high-pitched sound, commonly known as &quot;snoring&quot;, is one&#xD;
      of the common adverse reactions of chemotherapy. Intractable hiccups seriously affect the&#xD;
      rest and eating of patients, reduce the quality of life, and increasingly attract the&#xD;
      attention of oncologists. At present, the drugs or methods used in the treatment of&#xD;
      chemotherapy-related hiccups mainly include chlorpromazine, Ritalin, diazepam, phenacetin,&#xD;
      metoclopramide and traditional Chinese medicine, but these drugs or treatments usually have&#xD;
      poor efficacy and short remission time. The adverse reactions were serious and the clinical&#xD;
      use was not satisfactory. Baclofen is a gamma-aminobutyric acid (GABA) derivative that&#xD;
      activates the GABA-β receptor, inhibits the release of excitatory neurotransmitters, and&#xD;
      reduces monosynaptic or multisynaptic transmission in the spinal cord. Skeletal muscle&#xD;
      relaxation, originally used in patients with spinal cord injury, is gradually used to treat&#xD;
      intractable hiccups caused by diaphragmatic spasm.&#xD;
&#xD;
      This study was an open-label, randomized, prospective study comparing the efficacy and&#xD;
      adverse effects of baclofen versus metoclopramide in the treatment of chemotherapy-related&#xD;
      hiccups. Patients with hiccup after chemotherapy were randomly divided into two groups. One&#xD;
      group was treated with baclofen and the other group was treated with metoclopramide. The&#xD;
      efficacy and adverse reactions of the two groups were compared.Ineffective in the two groups&#xD;
      will cross to another group and then observe the efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 12, 2018</start_date>
  <completion_date type="Anticipated">December 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 11, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patient privacy needs to be protected</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effective rate</measure>
    <time_frame>3 days</time_frame>
    <description>Effective rate includes complete response rate and partial response rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions</measure>
    <time_frame>3 days</time_frame>
    <description>Adverse reactions include drowsiness, dizziness, sedation, tremors, etc.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hiccup</condition>
  <arm_group>
    <arm_group_label>Baclofen group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of Chemotherapy-related Hiccups With Baclofen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methoxyclopramide group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment of Chemotherapy-related Hiccups With Methoxyclopramide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baclofen group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methoxyclopramide group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen</intervention_name>
    <description>Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects</description>
    <arm_group_label>Baclofen group</arm_group_label>
    <arm_group_label>Baclofen group 2</arm_group_label>
    <other_name>Baclofenum、Gabalon、Lioresal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methoxyclopramide</intervention_name>
    <description>Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects</description>
    <arm_group_label>Methoxyclopramide group</arm_group_label>
    <arm_group_label>Methoxyclopramide group 2</arm_group_label>
    <other_name>Detoxification</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological diagnosis of malignant tumors;PS score 0 ~ 3 points;&#xD;
&#xD;
          -  Hiccups occurred within 48 h after chemotherapy, lasting longer than 2 h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No serious heart, brain, lung, kidney and other diseases, no gastrointestinal&#xD;
             bleeding, no serious obstacles to blood clotting;&#xD;
&#xD;
          -  Blood routine and normal electrolyte of liver and kidney function before chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>long Huang, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Second Affiliated Hospital of Nanchang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>long Huang, Phd</last_name>
    <phone>13699549060</phone>
    <email>ndefy13211@ncu.edu.cn</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baclofen</keyword>
  <keyword>Chemotheropy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hiccup</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Baclofen</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/NCT03778281
org study id: HL002
nct id: NCT03778281
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hiccup is one of the common side effects of chemotherapy. Intractable hiccups seriously
      affect patients' rest and eating, reduce the quality of life, and increasingly attract the
      attention of oncologists. At present, drugs or methods for treating chemotherapy-related
      hiccups are generally ineffective, with short remission time, serious adverse reactions, and
      unsatisfactory clinical effects. Baclofen produces skeletal muscle relaxation and was
      originally used in patients with spinal cord injury, and has since been used to treat
      intractable hiccups caused by diaphragmatic spasm. This study was an open-label, randomized,
      prospective study comparing the efficacy and adverse effects of baclofen versus
      metoclopramide in the treatment of chemotherapy-related hiccups. Patients with hiccup after
      chemotherapy were randomly divided into two groups. One group was treated with baclofen and
      the other group was treated with metoclopramide. The efficacy and adverse reactions of the
      two groups were compared.Ineffective in the two groups will cross to another group and then
      observe the efficacy.
Hiccup is due to paroxysmal paralysis of the diaphragm, sudden inhalation of gas accompanied
      by rapid glottis closure and a short high-pitched sound, commonly known as "snoring", is one
      of the common adverse reactions of chemotherapy. Intractable hiccups seriously affect the
      rest and eating of patients, reduce the quality of life, and increasingly attract the
      attention of oncologists. At present, the drugs or methods used in the treatment of
      chemotherapy-related hiccups mainly include chlorpromazine, Ritalin, diazepam, phenacetin,
      metoclopramide and traditional Chinese medicine, but these drugs or treatments usually have
      poor efficacy and short remission time. The adverse reactions were serious and the clinical
      use was not satisfactory. Baclofen is a gamma-aminobutyric acid (GABA) derivative that
      activates the GABA-β receptor, inhibits the release of excitatory neurotransmitters, and
      reduces monosynaptic or multisynaptic transmission in the spinal cord. Skeletal muscle
      relaxation, originally used in patients with spinal cord injury, is gradually used to treat
      intractable hiccups caused by diaphragmatic spasm.

      This study was an open-label, randomized, prospective study comparing the efficacy and
      adverse effects of baclofen versus metoclopramide in the treatment of chemotherapy-related
      hiccups. Patients with hiccup after chemotherapy were randomly divided into two groups. One
      group was treated with baclofen and the other group was treated with metoclopramide. The
      efficacy and adverse reactions of the two groups were compared.Ineffective in the two groups
      will cross to another group and then observe the efficacy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Patient privacy needs to be protected
measure: Effective rate
time frame: 3 days
description: Effective rate includes complete response rate and partial response rate
measure: Adverse reactions
time frame: 3 days
description: Adverse reactions include drowsiness, dizziness, sedation, tremors, etc.
arm group label: Baclofen group
arm group type: Experimental
description: Treatment of Chemotherapy-related Hiccups With Baclofen
arm group label: Methoxyclopramide group
arm group type: Other
description: Treatment of Chemotherapy-related Hiccups With Methoxyclopramide
arm group label: Baclofen group 2
arm group type: Experimental
description: After 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2.
arm group label: Methoxyclopramide group 2
arm group type: Other
description: After 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2.
intervention type: Drug
intervention name: Baclofen
description: Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
arm group label: Baclofen group
arm group label: Baclofen group 2
other name: Baclofenum、Gabalon、Lioresal
intervention type: Drug
intervention name: Methoxyclopramide
description: Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
arm group label: Methoxyclopramide group
arm group label: Methoxyclopramide group 2
other name: Detoxification
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: long Huang, Phd
role: Study Director
affiliation: Second Affiliated Hospital of Nanchang University
last name: long Huang, Phd
phone: 13699549060
email: ndefy13211@ncu.edu.cn
responsible party type: Sponsor
mesh term: Hiccup
mesh term: Baclofen
sharing ipd: No