<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/NCT03755921</url>
  </required_header>
  <id_info>
    <org_study_id>TBI2018</org_study_id>
    <nct_id>NCT03755921</nct_id>
  </id_info>
  <brief_title>Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer</brief_title>
  <acronym>dysphagia</acronym>
  <official_title>The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</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>
      According to data in the literature, patients with head and neck cancer, who undergo combined&#xD;
      treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes.&#xD;
      Most of the time, these patients undergo traditional speech-language interventions, performed&#xD;
      weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily&#xD;
      interventions, showing that this therapeutic modality generates benefits in a shorter time&#xD;
      interval when compared to traditional therapy. This short service period contributes to the&#xD;
      reduction of hospital costs and reduces the total number of interventions, which is&#xD;
      beneficial for both the patient and the service that performs the care. The present study was&#xD;
      to verify the efficacy of a brief and intensive therapy program for dysphagia in patients&#xD;
      with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to&#xD;
      a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot&#xD;
      project that will be developed in an oncology hospital. The population of this study is&#xD;
      composed of patients diagnosed with head and neck cancer, over 18 years of age, with&#xD;
      indication of combined radiotherapy , referred for speech therapy through the&#xD;
      Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      he sample will consist of 20 patients who will be randomized into two groups: 10 in the&#xD;
      intervention group with intensive brief therapy and 10 in the control group with traditional&#xD;
      weekly therapy. In both groups, instruments related to swallowing assessment and quality of&#xD;
      life will be applied before and after speech therapy. The control group will receive speech&#xD;
      therapy with weekly frequency, and the intervention group will participate in a brief and&#xD;
      intensive therapy program that will take place during five days a week for three weeks,&#xD;
      totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the&#xD;
      patients will receive care of individualized form, according to their needs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2018</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>
    <intervention_model_description>The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>M. D. Anderson Dysphagia Inventory (MDADI)</measure>
    <time_frame>3 months average</time_frame>
    <description>41/5000 quality of life parameter, questionnaire.Questionnaire developed by Chen et al. (2001) and validated by Guedes et al. (2013) With the objective of evaluating the quality of life of patients. consisting of 20 items, involving global, physical, functional and emotional domains, with objective of assessing the impact of dysphagia on the quality of life of patients who underwent treatment of head and neck cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Oral Intake Scale</measure>
    <time_frame>3 months average</time_frame>
    <description>oral intake, skale. It is composed by a seven-level scale, which graduates oral intake of patients.&#xD;
Scale of seven levels, graduates the oral intake of patients. At level 1, the patient is exclusively using an alternative feeding route, with no oral conditions. At levels 2 and 3, it still depends on a consistency. At levels 4,5 and 6 it can be oral total in one of the most consistencies, with or without compensation, but with some restrictions. At level 7, the patient had total oral conditions, without restrictions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iowa Oral Performance Instrument (IOPI)</measure>
    <time_frame>3 months average</time_frame>
    <description>strength of language, assessment, equipment. Instrument developed in 1992, which allows to evaluate the strength and resistance of the tongue, by inserting a bulb into the oral cavity. The patient should lift the dorsum, and / or the anterior portion of the tongue against this bulb, pushing as hard as he can. Afterwards, the pressure transducer circuits of the apparatus will detect bulb compression, indicating the peak pressure result (Solomon et al, 2008; Robins et al, 2007).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deglutition evaluation</measure>
    <time_frame>3 months average</time_frame>
    <description>evaluation of swallowing, protocol. In the structural evaluation (normal or altered), morphological (normal or altered) deglutitionstrength (normal or flaccid), mobility (normal or reduced), coordination (normal or altered) and sensitivity (normal or reduced), swallowing reflex (present or ausent), clinical signs suggestive of penetration / aspiration (present or ausent).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Deglutition Disorders</condition>
  <condition>Dysphagia</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Radiotherapy; Complications</condition>
  <arm_group>
    <arm_group_label>Brief and intensive therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapy Weekly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bried and intensive therapy</intervention_name>
    <description>Speech Therapy Exercises</description>
    <arm_group_label>Brief and intensive therapy</arm_group_label>
    <arm_group_label>Therapy Weekly</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients from 18 years of age;&#xD;
&#xD;
          -  Diagnosis of head and neck cancer;&#xD;
&#xD;
          -  Indication of combined treatment of radio-chemotherapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have performed prior speech and hearing care for at least three months prior to the&#xD;
             start of the study;&#xD;
&#xD;
          -  Previous history of other neoplasias and / or neurological diseases, according to the&#xD;
             participant's report and information of the medical record;&#xD;
&#xD;
          -  Cognitive deficits and / or changes in the central nervous system that make it&#xD;
             difficult to understand commands (illiterate individuals will have scores of at least&#xD;
             20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8&#xD;
             years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according&#xD;
             to Brucki et al., 2003).&#xD;
&#xD;
          -  Cardiac problems, according to the participant's report and information on the medical&#xD;
             chart.&#xD;
&#xD;
          -  Do not attend therapy for more than three sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Fabrício Edler Macagnan</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </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>Deglutition Disorders</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/NCT03755921
org study id: TBI2018
nct id: NCT03755921
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
According to data in the literature, patients with head and neck cancer, who undergo combined
      treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes.
      Most of the time, these patients undergo traditional speech-language interventions, performed
      weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily
      interventions, showing that this therapeutic modality generates benefits in a shorter time
      interval when compared to traditional therapy. This short service period contributes to the
      reduction of hospital costs and reduces the total number of interventions, which is
      beneficial for both the patient and the service that performs the care. The present study was
      to verify the efficacy of a brief and intensive therapy program for dysphagia in patients
      with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to
      a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot
      project that will be developed in an oncology hospital. The population of this study is
      composed of patients diagnosed with head and neck cancer, over 18 years of age, with
      indication of combined radiotherapy , referred for speech therapy through the
      Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).
he sample will consist of 20 patients who will be randomized into two groups: 10 in the
      intervention group with intensive brief therapy and 10 in the control group with traditional
      weekly therapy. In both groups, instruments related to swallowing assessment and quality of
      life will be applied before and after speech therapy. The control group will receive speech
      therapy with weekly frequency, and the intervention group will participate in a brief and
      intensive therapy program that will take place during five days a week for three weeks,
      totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the
      patients will receive care of individualized form, according to their needs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs
primary purpose: Other
masking: Double (Participant, Investigator)
measure: M. D. Anderson Dysphagia Inventory (MDADI)
time frame: 3 months average
description: 41/5000 quality of life parameter, questionnaire.Questionnaire developed by Chen et al. (2001) and validated by Guedes et al. (2013) With the objective of evaluating the quality of life of patients. consisting of 20 items, involving global, physical, functional and emotional domains, with objective of assessing the impact of dysphagia on the quality of life of patients who underwent treatment of head and neck cancer
measure: Functional Oral Intake Scale
time frame: 3 months average
description: oral intake, skale. It is composed by a seven-level scale, which graduates oral intake of patients.
Scale of seven levels, graduates the oral intake of patients. At level 1, the patient is exclusively using an alternative feeding route, with no oral conditions. At levels 2 and 3, it still depends on a consistency. At levels 4,5 and 6 it can be oral total in one of the most consistencies, with or without compensation, but with some restrictions. At level 7, the patient had total oral conditions, without restrictions.
measure: Iowa Oral Performance Instrument (IOPI)
time frame: 3 months average
description: strength of language, assessment, equipment. Instrument developed in 1992, which allows to evaluate the strength and resistance of the tongue, by inserting a bulb into the oral cavity. The patient should lift the dorsum, and / or the anterior portion of the tongue against this bulb, pushing as hard as he can. Afterwards, the pressure transducer circuits of the apparatus will detect bulb compression, indicating the peak pressure result (Solomon et al, 2008; Robins et al, 2007).
measure: Deglutition evaluation
time frame: 3 months average
description: evaluation of swallowing, protocol. In the structural evaluation (normal or altered), morphological (normal or altered) deglutitionstrength (normal or flaccid), mobility (normal or reduced), coordination (normal or altered) and sensitivity (normal or reduced), swallowing reflex (present or ausent), clinical signs suggestive of penetration / aspiration (present or ausent).
arm group label: Brief and intensive therapy
arm group type: Experimental
description: exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily
arm group label: Therapy Weekly
arm group type: Active Comparator
description: exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly
intervention type: Other
intervention name: bried and intensive therapy
description: Speech Therapy Exercises
arm group label: Brief and intensive therapy
arm group label: Therapy Weekly
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Fabrício Edler Macagnan
investigator title: Clinical professor
mesh term: Head and Neck Neoplasms
mesh term: Deglutition Disorders
sharing ipd: No