<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/NCT03818347</url>
  </required_header>
  <id_info>
    <org_study_id>Hydrogen-cancer</org_study_id>
    <nct_id>NCT03818347</nct_id>
  </id_info>
  <brief_title>Hydrogen Gas for Cancer Rehabilitation</brief_title>
  <official_title>Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuda Cancer Hospital, Guangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Asclepius Meditech Co., Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fuda Cancer Hospital, Guangzhou</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>
      The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and&#xD;
      prognosis of cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By enrolling patients of multiple kinds of cancer adapted to enrolled criteria, this study&#xD;
      will document for the first time the short and long term efficacy of hydrogen gas.The&#xD;
      evaluation indexes include peripheral blood lymphocyte immunoassay, improvement of sleep,&#xD;
      diet and exercise, progress free survival (PFS) and overall survival (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2018</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>the patients will inhale hydrogen and oxygen with oxyhydrogen generator</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>the experimental and control machines are of the same appearance and gas generation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of sleep, diet and exercise</measure>
    <time_frame>3 months</time_frame>
    <description>It will be evaluated by the questionnaire of EORTC QLQ-C30. The scores of each index before and after treatment need to be analyzed by statistical methods to reach a conclusion, and P&lt; 0.05 is considered to be statistically different</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement of immune function</measure>
    <time_frame>3 months</time_frame>
    <description>It will be evaluated by the blood test, including tumor marker alpha fetoprotein (AFP), lymphocyte subsets (T and NK cells) and circulating tumor cell (CTCs). The reference range of AFP is 0-40 IU/mL, higher than this range indicates tumor risk, and the higher the value is, the faster the tumor growth rate will be. The t-cell range of the lymphocyte subclass is 603-2990 cell/uL, and the NK cell range is 95-640 cell/uL, lower than the reference range indicates low immune function. The CTC reference range is 0-1, and higher than the reference range indicates tumor activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival（PFS）</measure>
    <time_frame>1 year</time_frame>
    <description>follow-up of CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival（OS）</measure>
    <time_frame>3 years</time_frame>
    <description>follow-up survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Adult Solid Tumor</condition>
  <arm_group>
    <arm_group_label>oxyhydrogen generator (AMS-H-03)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Model: AMS-H-03 Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively In this group, the patients will inhale hydrogen and oxygen with oxyhydrogen generator. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In this group, the patients will inhale normal air with analogue machine. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oxyhydrogen generator (AMS-H-03)</intervention_name>
    <description>Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively. The patients inhale 3 hours each day through a cannula or mask, and persist for long term</description>
    <arm_group_label>oxyhydrogen generator (AMS-H-03)</arm_group_label>
    <other_name>hydrogen generator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>analogue machine</intervention_name>
    <description>This machine has the same apperance and gas condition</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Standard therapies have finished according to NCCN guidelines or the patient refuses&#xD;
             standard therapies&#xD;
&#xD;
          -  Body tumor 1-6, the maximum tumor length &lt; 2 cm&#xD;
&#xD;
          -  KPS ≥ 70, lifespan &gt; 6 months&#xD;
&#xD;
          -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥&#xD;
             2×109/L, hemoglobin ≥ 80 g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac pacemaker&#xD;
&#xD;
          -  Patients with brain metastasis&#xD;
&#xD;
          -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and&#xD;
             pulmonary dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangzhou Fuda cancer institute</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510665</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid tumor</keyword>
  <keyword>Hydrogen gas</keyword>
  <!-- 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/NCT03818347
org study id: Hydrogen-cancer
nct id: NCT03818347
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and
      prognosis of cancer patients.
By enrolling patients of multiple kinds of cancer adapted to enrolled criteria, this study
      will document for the first time the short and long term efficacy of hydrogen gas.The
      evaluation indexes include peripheral blood lymphocyte immunoassay, improvement of sleep,
      diet and exercise, progress free survival (PFS) and overall survival (OS).
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: the patients will inhale hydrogen and oxygen with oxyhydrogen generator
primary purpose: Treatment
masking: Single (Investigator)
masking description: the experimental and control machines are of the same appearance and gas generation
measure: Improvement of sleep, diet and exercise
time frame: 3 months
description: It will be evaluated by the questionnaire of EORTC QLQ-C30. The scores of each index before and after treatment need to be analyzed by statistical methods to reach a conclusion, and P< 0.05 is considered to be statistically different
measure: Improvement of immune function
time frame: 3 months
description: It will be evaluated by the blood test, including tumor marker alpha fetoprotein (AFP), lymphocyte subsets (T and NK cells) and circulating tumor cell (CTCs). The reference range of AFP is 0-40 IU/mL, higher than this range indicates tumor risk, and the higher the value is, the faster the tumor growth rate will be. The t-cell range of the lymphocyte subclass is 603-2990 cell/uL, and the NK cell range is 95-640 cell/uL, lower than the reference range indicates low immune function. The CTC reference range is 0-1, and higher than the reference range indicates tumor activity.
measure: Progress free survival（PFS）
time frame: 1 year
description: follow-up of CT scan
measure: Overall survival（OS）
time frame: 3 years
description: follow-up survival
arm group label: oxyhydrogen generator (AMS-H-03)
arm group type: Experimental
description: Model: AMS-H-03 Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively In this group, the patients will inhale hydrogen and oxygen with oxyhydrogen generator. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Control
arm group type: Placebo Comparator
description: In this group, the patients will inhale normal air with analogue machine. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
intervention type: Device
intervention name: oxyhydrogen generator (AMS-H-03)
description: Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively. The patients inhale 3 hours each day through a cannula or mask, and persist for long term
arm group label: oxyhydrogen generator (AMS-H-03)
other name: hydrogen generator
intervention type: Device
intervention name: analogue machine
description: This machine has the same apperance and gas condition
arm group label: Control
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor