Tongue CancerNCT04126226
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
A study testing Speech-language guidance, Speech therapy exercises for swallowing and Speech therapy exercises for speech in people with Tongue Cancer and Jaw Cancer, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Cancer, Jaw Cancer, Oral Cancer
- What is being tested?
- Speech-language guidance, Speech therapy exercises for swallowing and Speech therapy exercises for speech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 Years
- Tongue and/or Jaw Neoplasm
- Submitted to surgical treatment
Who cannot join
- Under 18 Years
- Cognitive impairment or deficits in language comprehension
- Previous speech therapy intervention
- Recurrence or active disease
- Death during the intervention
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
About this study
Official title: Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial
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.
- Conditions
- Tongue Cancer, Jaw Cancer, Oral Cancer, Intelligibility, Speech
- Being tested
- Speech-language guidance, Speech therapy exercises for swallowing, Speech therapy exercises for speech
- Keywords
- Speech therapy, Dysphagia, Speech Intelligibility, Quality of Life
- Medical subject headings
- Tongue Neoplasms, Jaw Neoplasms, Mouth Neoplasms, Speech Intelligibility, Communication Disorders, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Speech-language guidance; Other: Speech therapy exercises for swallowing; Other: Speech therapy exercises for speech |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 1 month
Secondary outcomes (2)
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
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Mar 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue CancerStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sady S da Costa, PHD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126226
- Sponsor's protocol ID
- 96487218300005327
- Status last verified
- Jul 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04126226
- Acronym / sponsor ID
- 96487218300005327
- Conditions
- Tongue Cancer, Jaw Cancer, Oral Cancer, Intelligibility, Speech
- Keywords
- Speech therapy, Dysphagia, Speech Intelligibility, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Speech-language guidance, Other: Speech therapy exercises for swallowing, Other: Speech therapy exercises for speech |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 Years
- Tongue and/or Jaw Neoplasm
- Submitted to surgical treatment
Key exclusion criteria (5 listed)
- Under 18 Years
- Cognitive impairment or deficits in language comprehension
- Previous speech therapy intervention
- Recurrence or active disease
- Death during the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech-language guidanceSpeech-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. | Other | Study group |
| Speech therapy exercises for swallowingUse of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month. | Other | Study group |
| Speech therapy exercises for speechUse of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month. | Other | Study group |
Primary outcome
Changes in Quality of Life Scores related to swallowing
Time frame: 1 month
To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)
Changes in Quality of Life Scores related to speech
Time frame: 1 month
To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)
2 secondary outcomes
Changes in Dysphagia Classification
Time frame: 1 month
Changes in Speech Intelligibility Classification
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sady S da Costa, PHD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-language guidance, Speech therapy exercises for swallowing and Speech therapy exercises for speech in people with Tongue Cancer and Jaw Cancer, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life Scores related to swallowing (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.