<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/NCT03776578</url>
  </required_header>
  <id_info>
    <org_study_id>201807023RINA</org_study_id>
    <nct_id>NCT03776578</nct_id>
  </id_info>
  <brief_title>Oral Cancer With Wide Excision and Free Flap Reconstruction</brief_title>
  <official_title>Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A proactive speech-language pathologist program can be successfully established as part of&#xD;
      the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve&#xD;
      patient quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head and neck cancer treatment has developed over the last decade, with improved mortality&#xD;
      and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing)&#xD;
      as a side effect. Swallowing function is affected by the tumor itself, surgical resection of&#xD;
      the lesion and neoadjuvant chemoradiation therapy. It is well accepted that pre-treatment&#xD;
      swallow function is indicative of post-treatment status and is helpful in identifying&#xD;
      patients with high risk of aspiration and dysphagia. In recent years, the concept of &quot;use it,&#xD;
      or lose it&quot; has been widely advocated by specialists. Preventive swallowing rehabilitation&#xD;
      including evaluation patient's swallowing function and propose rehabilitation and adaptive&#xD;
      maneuver or change in food texture. The aim is to ensure safe swallowing and prevent&#xD;
      deglutitive muscles from deconditioning. Moreover, aspiration can be prevented and adequate&#xD;
      nutrition was maintained through the cancer treatment course. Investigators include patients&#xD;
      with advanced oral cavity cancer who were treated by radical operation and free flap&#xD;
      reconstruction, and provided them with preventive swallowing rehabilitation. Investigators&#xD;
      then analyze the swallowing function, oral intake status, and nasogastric tube dependence&#xD;
      rate and tracheostomy tube dependence rate.The participants received interventions as part of&#xD;
      our routine medical care, and Investigators studied the effect of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>nasogastric tube dependence rate</measure>
    <time_frame>2 years</time_frame>
    <description>nasogastric tube dependence rate</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Head and neck Cancer surgery not treatment and rehabilitation</arm_group_label>
    <description>The patients with oral cavity cancer who weren't treated by radical operation and free flap reconstruction,and can't provide them with preventive swallowing rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head and neck Cancer surgery treatment and rehabilitation</arm_group_label>
    <description>Head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia.Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation.Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>swallow fuction and swallow training</intervention_name>
    <description>nasogastric tube dependence rate</description>
    <arm_group_label>Head and neck Cancer surgery treatment and rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For all outcome measures, descriptive statistics were generated. Statistical analysis will&#xD;
        be performed using the Statistical Package of Social Sciences (SPSS) software version 23.0.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Advanced Oral Cancer Patients Treated with Wide Excision and Free Flap Reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not willing to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Hsuan Tseng</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wen-Hsuan Tseng</last_name>
    <phone>0972652672</phone>
    <email>alts074@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wen-Hsuan Tseng</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen-Hsuan Tseng</last_name>
      <phone>0972652672</phone>
      <email>alts074@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Goepfert RP, Lewin JS, Barrow MP, Gunn GB, Fuller CD, Beadle BM, Garden AS, Rosenthal DI, Kies MS, Papadimitrakopoulou V, Lai SY, Gross ND, Schwartz DL, Hutcheson KA. Long-Term, Prospective Performance of the MD Anderson Dysphagia Inventory in &quot;Low-Intermediate Risk&quot; Oropharyngeal Carcinoma After Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):700-708. doi: 10.1016/j.ijrobp.2016.06.010. Epub 2016 Jun 15.</citation>
    <PMID>27485284</PMID>
  </reference>
  <reference>
    <citation>Goepfert RP, Lewin JS, Barrow MP, Fuller CD, Lai SY, Song J, Hobbs BP, Gunn GB, Beadle BM, Rosenthal DI, Garden AS, Kies MS, Papadimitrakopoulou VA, Schwartz DL, Hutcheson KA. Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma. Laryngoscope. 2017 Apr;127(4):842-848. doi: 10.1002/lary.26153. Epub 2016 Jul 21.</citation>
    <PMID>27440393</PMID>
  </reference>
  <results_reference>
    <citation>Perry A, Lee SH, Cotton S, Kennedy C. Therapeutic exercises for affecting post-treatment swallowing in people treated for advanced-stage head and neck cancers. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011112. doi: 10.1002/14651858.CD011112.pub2.</citation>
    <PMID>27562477</PMID>
  </results_reference>
  <results_reference>
    <citation>Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.</citation>
    <PMID>28766850</PMID>
  </results_reference>
  <results_reference>
    <citation>Ajmani GS, Nocon CC, Brockstein BE, Campbell NP, Kelly AB, Allison J, Bhayani MK. Association of a Proactive Swallowing Rehabilitation Program With Feeding Tube Placement in Patients Treated for Pharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2018 Jun 1;144(6):483-488. doi: 10.1001/jamaoto.2018.0278.</citation>
    <PMID>29710108</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>protocal,patient treantment course</ipd_description>
  </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/NCT03776578
org study id: 201807023RINA
nct id: NCT03776578
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A proactive speech-language pathologist program can be successfully established as part of
      the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve
      patient quality of life.
Head and neck cancer treatment has developed over the last decade, with improved mortality
      and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing)
      as a side effect. Swallowing function is affected by the tumor itself, surgical resection of
      the lesion and neoadjuvant chemoradiation therapy. It is well accepted that pre-treatment
      swallow function is indicative of post-treatment status and is helpful in identifying
      patients with high risk of aspiration and dysphagia. In recent years, the concept of "use it,
      or lose it" has been widely advocated by specialists. Preventive swallowing rehabilitation
      including evaluation patient's swallowing function and propose rehabilitation and adaptive
      maneuver or change in food texture. The aim is to ensure safe swallowing and prevent
      deglutitive muscles from deconditioning. Moreover, aspiration can be prevented and adequate
      nutrition was maintained through the cancer treatment course. Investigators include patients
      with advanced oral cavity cancer who were treated by radical operation and free flap
      reconstruction, and provided them with preventive swallowing rehabilitation. Investigators
      then analyze the swallowing function, oral intake status, and nasogastric tube dependence
      rate and tracheostomy tube dependence rate.The participants received interventions as part of
      our routine medical care, and Investigators studied the effect of the intervention.
observational model: Other
time perspective: Other
measure: nasogastric tube dependence rate
time frame: 2 years
description: nasogastric tube dependence rate
arm group label: Head and neck Cancer surgery not treatment and rehabilitation
description: The patients with oral cavity cancer who weren't treated by radical operation and free flap reconstruction,and can't provide them with preventive swallowing rehabilitation
arm group label: Head and neck Cancer surgery treatment and rehabilitation
description: Head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia.Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation.Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.
intervention type: Procedure
intervention name: swallow fuction and swallow training
description: nasogastric tube dependence rate
arm group label: Head and neck Cancer surgery treatment and rehabilitation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wen-Hsuan Tseng
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Wen-Hsuan Tseng
phone: 0972652672
email: alts074@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Goepfert RP, Lewin JS, Barrow MP, Gunn GB, Fuller CD, Beadle BM, Garden AS, Rosenthal DI, Kies MS, Papadimitrakopoulou V, Lai SY, Gross ND, Schwartz DL, Hutcheson KA. Long-Term, Prospective Performance of the MD Anderson Dysphagia Inventory in "Low-Intermediate Risk" Oropharyngeal Carcinoma After Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):700-708. doi: 10.1016/j.ijrobp.2016.06.010. Epub 2016 Jun 15.
PMID: 27485284
citation: Goepfert RP, Lewin JS, Barrow MP, Fuller CD, Lai SY, Song J, Hobbs BP, Gunn GB, Beadle BM, Rosenthal DI, Garden AS, Kies MS, Papadimitrakopoulou VA, Schwartz DL, Hutcheson KA. Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma. Laryngoscope. 2017 Apr;127(4):842-848. doi: 10.1002/lary.26153. Epub 2016 Jul 21.
PMID: 27440393
citation: Perry A, Lee SH, Cotton S, Kennedy C. Therapeutic exercises for affecting post-treatment swallowing in people treated for advanced-stage head and neck cancers. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011112. doi: 10.1002/14651858.CD011112.pub2.
PMID: 27562477
citation: Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.
PMID: 28766850
citation: Ajmani GS, Nocon CC, Brockstein BE, Campbell NP, Kelly AB, Allison J, Bhayani MK. Association of a Proactive Swallowing Rehabilitation Program With Feeding Tube Placement in Patients Treated for Pharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2018 Jun 1;144(6):483-488. doi: 10.1001/jamaoto.2018.0278.
PMID: 29710108
responsible party type: Sponsor
mesh term: Mouth Neoplasms
sharing ipd: No
ipd description: protocal,patient treantment course