Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy

Oral Cancer Clinical Trial

Official title:

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126226
• Other study ID #: 96487218300005327
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing.

The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 Years

• Tongue and/or Jaw Neoplasm

• Submitted to surgical treatment

Exclusion Criteria:

• Under 18 Years

• Cognitive impairment or deficits in language comprehension

• Previous speech therapy intervention

• Recurrence or active disease

• Death during the intervention

Related Conditions & MeSH terms

• Communication Disorders
• Intelligibility, Speech
• Jaw Cancer
• Mouth Neoplasms
• Oral Cancer
• Tongue Cancer
• Tongue Neoplasms

Intervention

Other:
• Speech-language guidance
Speech-language guidance for speech enhancement and on food management in terms of consistency, volumes, utensils and temperature, beyond the care for safe and efficient swallowing.
• Speech therapy exercises for swallowing
Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.
• Speech therapy exercises for speech
Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Life Scores related to swallowing	To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)	1 month
Primary	Changes in Quality of Life Scores related to speech	To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)	1 month
Secondary	Changes in Dysphagia Classification	To measure the changes in Dysphagia classification it was used the Fiberoptic Endoscopic Evaluation of Swallowing, exam that evaluate the functionability of swallow. These exams were presented to three judges (speech therapists) that in agreement classified the degree of dysphagia	1 month
Secondary	Changes in Speech Intelligibility Classification	To measure the changes in Speech Intelligibility it was used speech recordings that were analysed by three judges (speech therapists) that in agreement classified the degree of speech intelligibility	1 month