<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/NCT03037840</url>
  </required_header>
  <id_info>
    <org_study_id>SXXin-AM-RF-EMF-in vivo</org_study_id>
    <nct_id>NCT03037840</nct_id>
  </id_info>
  <brief_title>Detecting Tumor Specific Amplitude-modulated Frequencies of Cancer Patients</brief_title>
  <official_title>Detecting Tumor Specific Amplitude-modulated Frequencies of Cancer Patients In Vivo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong 999 Brain Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The 157th Hospital of PLA,China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southern Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that tumor specific amplitude-modulated frequencies of radiofrequency&#xD;
      electromagnetic fields that is associated with biofeedback upon exposure to in cancer&#xD;
      patients. However, such discovery in other cancer patients are rare. And whether tumor&#xD;
      specific frequencies can be found in Asian cancer patients remains unclear. The purpose of&#xD;
      this study is to detect the tumor specific frequencies of Asian cancer patients in vivo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The measurements were safety guaranteed and were conducted in hospital. Before detecting, the&#xD;
      patient will be already diagnosed with cancer. The doctor and the operator are responsible&#xD;
      for the detecting. When cancer patients are exposure to the RF electromagnetic fields, the&#xD;
      radial pulse amplitude, blood pressure, skin electrical resistance and breath will be&#xD;
      monitored. Biofeedback parameters will be recorded at different modulation frequencies and&#xD;
      analyzed in order to find the variation and tumor specific frequencies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biofeedback response of cancer patients at the exposure of Low intensity amplitude-modulated radiofrequency electromagnetic fields</measure>
    <time_frame>within 20 min of exposure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Representation of autonomous response during the exposure of tumor specific frequencies modutated RF eletromagnetic fields</measure>
    <time_frame>within 20 min of exposure</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>cancer patients</arm_group_label>
    <description>Low intensity amplitude-modulated RF EMFs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy participators</arm_group_label>
    <description>Low intensity amplitude-modulated RF EMFs</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low intensity amplitude-modulated RF EMFs</intervention_name>
    <description>Low intensity amplitude-modulated radiofrequency electromagnetic fields,the carrier frequency is 27.12MHz with a power of about 100mW</description>
    <arm_group_label>cancer patients</arm_group_label>
    <arm_group_label>healthy participators</arm_group_label>
    <other_name>Low intensity AM RF EMFs</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. The patients who are diagnosed with cancer disease&#xD;
&#xD;
          2. Healthy participators&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of cancer Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Sherman Xuegang, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Biomedical Engineering,Southern Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cai Linbo, master</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong 999 Brain Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhu Xiaoxia, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liu Xiantang, bachelor</last_name>
    <role>Study Director</role>
    <affiliation>The 157th Hospital of PLA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xin Sherman Xuegang, professor</last_name>
    <phone>008613602733465</phone>
    <email>xxg@smu.edu.cn</email>
  </overall_contact>
  <reference>
    <citation>Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, Pasche B. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.</citation>
    <PMID>19366446</PMID>
  </reference>
  <reference>
    <citation>Costa FP, de Oliveira AC, Meirelles R, Machado MC, Zanesco T, Surjan R, Chammas MC, de Souza Rocha M, Morgan D, Cantor A, Zimmerman J, Brezovich I, Kuster N, Barbault A, Pasche B. Treatment of advanced hepatocellular carcinoma with very low levels of amplitude-modulated electromagnetic fields. Br J Cancer. 2011 Aug 23;105(5):640-8. doi: 10.1038/bjc.2011.292. Epub 2011 Aug 9.</citation>
    <PMID>21829195</PMID>
  </reference>
  <reference>
    <citation>Zimmerman JW, Pennison MJ, Brezovich I, Yi N, Yang CT, Ramaker R, Absher D, Myers RM, Kuster N, Costa FP, Barbault A, Pasche B. Cancer cell proliferation is inhibited by specific modulation frequencies. Br J Cancer. 2012 Jan 17;106(2):307-13. doi: 10.1038/bjc.2011.523. Epub 2011 Dec 1.</citation>
    <PMID>22134506</PMID>
  </reference>
  <reference>
    <citation>Zimmerman JW, Jimenez H, Pennison MJ, Brezovich I, Morgan D, Mudry A, Costa FP, Barbault A, Pasche B. Targeted treatment of cancer with radiofrequency electromagnetic fields amplitude-modulated at tumor-specific frequencies. Chin J Cancer. 2013 Nov;32(11):573-81. doi: 10.5732/cjc.013.10177.</citation>
    <PMID>24206915</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 6, 2016</study_first_submitted>
  <study_first_submitted_qc>July 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southern Medical University, China</investigator_affiliation>
    <investigator_full_name>Sherman Xuegang Xin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>RF EMF</keyword>
  <keyword>In Vivo</keyword>
  <keyword>tumor specific frequencies</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03037840
org study id: SXXin-AM-RF-EMF-in vivo
nct id: NCT03037840
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Studies have shown that tumor specific amplitude-modulated frequencies of radiofrequency
      electromagnetic fields that is associated with biofeedback upon exposure to in cancer
      patients. However, such discovery in other cancer patients are rare. And whether tumor
      specific frequencies can be found in Asian cancer patients remains unclear. The purpose of
      this study is to detect the tumor specific frequencies of Asian cancer patients in vivo.
The measurements were safety guaranteed and were conducted in hospital. Before detecting, the
      patient will be already diagnosed with cancer. The doctor and the operator are responsible
      for the detecting. When cancer patients are exposure to the RF electromagnetic fields, the
      radial pulse amplitude, blood pressure, skin electrical resistance and breath will be
      monitored. Biofeedback parameters will be recorded at different modulation frequencies and
      analyzed in order to find the variation and tumor specific frequencies.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Biofeedback response of cancer patients at the exposure of Low intensity amplitude-modulated radiofrequency electromagnetic fields
time frame: within 20 min of exposure
measure: Representation of autonomous response during the exposure of tumor specific frequencies modutated RF eletromagnetic fields
time frame: within 20 min of exposure
arm group label: cancer patients
description: Low intensity amplitude-modulated RF EMFs
arm group label: healthy participators
description: Low intensity amplitude-modulated RF EMFs
intervention type: Device
intervention name: Low intensity amplitude-modulated RF EMFs
description: Low intensity amplitude-modulated radiofrequency electromagnetic fields,the carrier frequency is 27.12MHz with a power of about 100mW
arm group label: cancer patients
arm group label: healthy participators
other name: Low intensity AM RF EMFs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xin Sherman Xuegang, professor
role: Principal Investigator
affiliation: School of Biomedical Engineering,Southern Medical University
last name: Cai Linbo, master
role: Study Director
affiliation: Guangdong 999 Brain Hospital
last name: Zhu Xiaoxia, PhD
role: Study Director
affiliation: Nanfang Hospital, Southern Medical University
last name: Liu Xiantang, bachelor
role: Study Director
affiliation: The 157th Hospital of PLA
last name: Xin Sherman Xuegang, professor
phone: 008613602733465
email: xxg@smu.edu.cn
citation: Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, Pasche B. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.
PMID: 19366446
citation: Costa FP, de Oliveira AC, Meirelles R, Machado MC, Zanesco T, Surjan R, Chammas MC, de Souza Rocha M, Morgan D, Cantor A, Zimmerman J, Brezovich I, Kuster N, Barbault A, Pasche B. Treatment of advanced hepatocellular carcinoma with very low levels of amplitude-modulated electromagnetic fields. Br J Cancer. 2011 Aug 23;105(5):640-8. doi: 10.1038/bjc.2011.292. Epub 2011 Aug 9.
PMID: 21829195
citation: Zimmerman JW, Pennison MJ, Brezovich I, Yi N, Yang CT, Ramaker R, Absher D, Myers RM, Kuster N, Costa FP, Barbault A, Pasche B. Cancer cell proliferation is inhibited by specific modulation frequencies. Br J Cancer. 2012 Jan 17;106(2):307-13. doi: 10.1038/bjc.2011.523. Epub 2011 Dec 1.
PMID: 22134506
citation: Zimmerman JW, Jimenez H, Pennison MJ, Brezovich I, Morgan D, Mudry A, Costa FP, Barbault A, Pasche B. Targeted treatment of cancer with radiofrequency electromagnetic fields amplitude-modulated at tumor-specific frequencies. Chin J Cancer. 2013 Nov;32(11):573-81. doi: 10.5732/cjc.013.10177.
PMID: 24206915
responsible party type: Principal Investigator
investigator affiliation: Southern Medical University, China
investigator full name: Sherman Xuegang Xin
investigator title: Professor
sharing ipd: Undecided