NCT04126226

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
Last Updated

October 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

October 11, 2019

Last Update Submit

October 11, 2019

Conditions

Tongue CancerJaw CancerOral CancerIntelligibility, Speech

Keywords

Speech therapyDysphagiaSpeech IntelligibilityQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Changes in Dysphagia Classification

    1 month

  • Changes in Speech Intelligibility Classification

    1 month

Study Arms (2)

Study group

EXPERIMENTAL
Other: Speech-language guidanceOther: Speech therapy exercises for swallowingOther: Speech therapy exercises for speech

Control Group

NO INTERVENTION

Interventions

Speech-language guidanceOTHER

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.

Study group
Speech therapy exercises for swallowingOTHER

Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.

Study group
Speech therapy exercises for speechOTHER

Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 Years
  • Tongue and/or Jaw Neoplasm
  • Submitted to surgical treatment

You may not qualify if:

  • Under 18 Years
  • Cognitive impairment or deficits in language comprehension
  • Previous speech therapy intervention
  • Recurrence or active disease
  • Death during the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

Location

MeSH Terms

Conditions

Tongue NeoplasmsJaw NeoplasmsMouth NeoplasmsSpeech IntelligibilityCommunication DisordersDeglutition Disorders

Interventions

Deglutition

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue DiseasesSkull NeoplasmsBone NeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesSpeechVerbal BehaviorCommunicationBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Sady S da Costa, PHD

    Hospital de Clínicas de Porto Alegre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

March 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)