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

NCT03755921 | Unknown

• 1 other identifier: TBI2018
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Deglutition Disorders; Dysphagia; Head and Neck Cancer; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional Oral Intake Scale

  3 months average

• Iowa Oral Performance Instrument (IOPI)

  3 months average

• Deglutition evaluation

  3 months average

Study Arms (2)

Brief and intensive therapy

EXPERIMENTAL

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

Therapy Weekly

ACTIVE COMPARATOR

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

Interventions

bried and intensive therapy OTHER

Speech Therapy Exercises

Brief and intensive therapy; Therapy Weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: 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 Record Dates

• First Submitted: July 9, 2018
• First Posted: November 28, 2018
• Study Start: December 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 30, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share