Clinical trial NCT03755921: Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
Official title: The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deglutition Disorders
Dysphagia
Head and Neck Cancer
Radiotherapy; Complications
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: M. D. Anderson Dysphagia Inventory (MDADI)
timeFrame: 3 months average
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: 3 months average
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: 3 months average
measure: Deglutition evaluation
timeFrame: 3 months average
Other outcomes:
Locations:
Study officials:
References: