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

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

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).

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer; Deglutition Disorders; Dysphagia; Radiotherapy; Complications
• Intervention / Treatment: Other: bried and intensive therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief and intensive therapy; exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily	Other: bried and intensive therapy; Speech Therapy Exercises
Active Comparator: Therapy Weekly; exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly	Other: bried and intensive therapy; Speech Therapy Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months average
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).	3 months average
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).	3 months average

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): January 30, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Head and Neck Neoplasms; Deglutition Disorders
• Other Study ID Numbers: TBI2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No