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Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer (dysphagia)

Primary Purpose

Deglutition Disorders, Dysphagia, Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bried and intensive therapy
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Deglutition Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients from 18 years of age;
  • Diagnosis of head and neck cancer;
  • Indication of combined treatment of radio-chemotherapy;

Exclusion Criteria:

  • Have performed prior speech and hearing care for at least three months prior to the start of the study;
  • Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record;
  • Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003).
  • Cardiac problems, according to the participant's report and information on the medical chart.
  • Do not attend therapy for more than three sessions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Brief and intensive therapy

    Therapy Weekly

    Arm Description

    exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily

    exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly

    Outcomes

    Primary Outcome Measures

    M. D. Anderson Dysphagia Inventory (MDADI)
    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

    Secondary Outcome Measures

    Functional Oral Intake Scale
    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.
    Iowa Oral Performance Instrument (IOPI)
    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).
    Deglutition evaluation
    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).

    Full Information

    First Posted
    July 9, 2018
    Last Updated
    November 26, 2018
    Sponsor
    Federal University of Health Science of Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03755921
    Brief Title
    Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
    Acronym
    dysphagia
    Official Title
    The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    December 15, 2018 (Anticipated)
    Study Completion Date
    January 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deglutition Disorders, Dysphagia, Head and Neck Cancer, Radiotherapy; Complications

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief and intensive therapy
    Arm Type
    Experimental
    Arm Description
    exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily
    Arm Title
    Therapy Weekly
    Arm Type
    Active Comparator
    Arm 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(s)
    bried and intensive therapy
    Intervention Description
    Speech Therapy Exercises
    Primary Outcome Measure Information:
    Title
    M. D. Anderson Dysphagia Inventory (MDADI)
    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
    Time Frame
    3 months average
    Secondary Outcome Measure Information:
    Title
    Functional Oral Intake Scale
    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.
    Time Frame
    3 months average
    Title
    Iowa Oral Performance Instrument (IOPI)
    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).
    Time Frame
    3 months average
    Title
    Deglutition evaluation
    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).
    Time Frame
    3 months average

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients from 18 years of age; Diagnosis of head and neck cancer; Indication of combined treatment of radio-chemotherapy; Exclusion Criteria: Have performed prior speech and hearing care for at least three months prior to the start of the study; Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record; Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003). Cardiac problems, according to the participant's report and information on the medical chart. Do not attend therapy for more than three sessions.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer

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