<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/NCT03751566</url>
  </required_header>
  <id_info>
    <org_study_id>MOU-001</org_study_id>
    <nct_id>NCT03751566</nct_id>
  </id_info>
  <brief_title>Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors</brief_title>
  <official_title>Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masaryk Memorial Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masaryk Memorial Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in&#xD;
      the therapy of acute toxicity of radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will enroll 100 patients in current radiotherapy of the head and neck cancer with&#xD;
      acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two&#xD;
      regimens 1:1.&#xD;
&#xD;
      Regimen A (control regimen): standard support treatment of adverse events of the&#xD;
      radiotherapy.&#xD;
&#xD;
      Regimen B (acupuncture regimen): standard support treatment of adverse events of the&#xD;
      radiotherapy and acupuncture.&#xD;
&#xD;
      Due to the disease and patients differences, treatment will be individualized. Used&#xD;
      acupuncture points will be documented. The patients difficulties will be observed and their&#xD;
      medication and will be recorded in the patient diary.&#xD;
&#xD;
      Possible skin toxicities wil be documented by the photography.&#xD;
&#xD;
      Before the randomization, all subjects will sign the voluntary informed consent. After the&#xD;
      achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the&#xD;
      other regimen.&#xD;
&#xD;
      Head and neck cancer therapy will include only curative and adjuvant radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 4, 2016</start_date>
  <completion_date type="Anticipated">October 4, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 4, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy</measure>
    <time_frame>six months after the end of radiotherapy</time_frame>
    <description>Reducing the grade of acute toxicity in radiotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy</measure>
    <time_frame>six months after the end of radiotherapy</time_frame>
    <description>Lower incidence of chronic toxicity of radiotherapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Malignant Tumor of Soft Tissue of Head, Face and Neck</condition>
  <arm_group>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Schedule of the acupuncture:&#xD;
Acupuncture may be done ambulant or during hospitalisation . Acupuncture will be administered 1-3 times a week ( in case of severe toxicity and problems caused by the radiotherapy, it may continue also after the termination of the radiotherapy.) Acupuncture needles will be left for 5- 30 minutes, as per individual need of the patients.&#xD;
Acupuncture will be performed by a physician trained in acupuncture.</description>
    <arm_group_label>Regimen B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard supportive therapy</intervention_name>
    <description>Standard supportive therapy</description>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Curative and adjuvant radiotherapy for head and neck tumors;&#xD;
&#xD;
          -  PS 1-2;&#xD;
&#xD;
          -  Patient collaboration in evaluation of the toxicity diary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Palliative radiotherapy in the head and neck tumor;&#xD;
&#xD;
          -  PS 3;&#xD;
&#xD;
          -  Non-compliance of the patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Renata Hejnová, Msc</last_name>
    <phone>+42054313</phone>
    <phone_ext>6232</phone_ext>
    <email>renata.hejnova@mou.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Regina Demlová, MD,Ph.D.</last_name>
    <email>demlova@mou.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Masaryk Memorial Cancer Institute</name>
      <address>
        <city>Brno</city>
        <zip>65653</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radana Dymáčková, MD</last_name>
      <phone>+42054313</phone>
      <phone_ext>1130</phone_ext>
      <email>radana.dymackova@mou.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Meng Z, Garcia MK, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Zhang Y, Zhao Q, Zhao G, Liu L, Spelman A, Palmer JL, Wei Q, Cohen L. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012 Jul 1;118(13):3337-44. doi: 10.1002/cncr.26550. Epub 2011 Nov 9.</citation>
    <PMID>22072272</PMID>
  </reference>
  <reference>
    <citation>Braga FP, Lemos Junior CA, Alves FA, Migliari DA. Acupuncture for the prevention of radiation-induced xerostomia in patients with head and neck cancer. Braz Oral Res. 2011 Mar-Apr;25(2):180-5. doi: 10.1590/s1806-83242011000200014.</citation>
    <PMID>21537645</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Soft Tissue Neoplasms</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
  </condition_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/NCT03751566
org study id: MOU-001
nct id: NCT03751566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in
      the therapy of acute toxicity of radiotherapy.
The study will enroll 100 patients in current radiotherapy of the head and neck cancer with
      acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two
      regimens 1:1.

      Regimen A (control regimen): standard support treatment of adverse events of the
      radiotherapy.

      Regimen B (acupuncture regimen): standard support treatment of adverse events of the
      radiotherapy and acupuncture.

      Due to the disease and patients differences, treatment will be individualized. Used
      acupuncture points will be documented. The patients difficulties will be observed and their
      medication and will be recorded in the patient diary.

      Possible skin toxicities wil be documented by the photography.

      Before the randomization, all subjects will sign the voluntary informed consent. After the
      achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the
      other regimen.

      Head and neck cancer therapy will include only curative and adjuvant radiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
time frame: six months after the end of radiotherapy
description: Reducing the grade of acute toxicity in radiotherapy.
measure: Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
time frame: six months after the end of radiotherapy
description: Lower incidence of chronic toxicity of radiotherapy.
arm group label: Regimen A
arm group type: Active Comparator
description: Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
arm group label: Regimen B
arm group type: Experimental
description: Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
intervention type: Other
intervention name: Acupuncture
description: Schedule of the acupuncture:
Acupuncture may be done ambulant or during hospitalisation . Acupuncture will be administered 1-3 times a week ( in case of severe toxicity and problems caused by the radiotherapy, it may continue also after the termination of the radiotherapy.) Acupuncture needles will be left for 5- 30 minutes, as per individual need of the patients.
Acupuncture will be performed by a physician trained in acupuncture.
arm group label: Regimen B
intervention type: Drug
intervention name: Standard supportive therapy
description: Standard supportive therapy
arm group label: Regimen A
arm group label: Regimen B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renata Hejnová, Msc
phone: +42054313
phone ext: 6232
email: renata.hejnova@mou.cz
last name: Regina Demlová, MD,Ph.D.
email: demlova@mou.cz
facility: 
status: Recruiting
contact: 
country: Czechia
citation: Meng Z, Garcia MK, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Zhang Y, Zhao Q, Zhao G, Liu L, Spelman A, Palmer JL, Wei Q, Cohen L. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012 Jul 1;118(13):3337-44. doi: 10.1002/cncr.26550. Epub 2011 Nov 9.
PMID: 22072272
citation: Braga FP, Lemos Junior CA, Alves FA, Migliari DA. Acupuncture for the prevention of radiation-induced xerostomia in patients with head and neck cancer. Braz Oral Res. 2011 Mar-Apr;25(2):180-5. doi: 10.1590/s1806-83242011000200014.
PMID: 21537645
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Soft Tissue Neoplasms
mesh term: Sarcoma
sharing ipd: No