Cancer of the LarynxNCT01607138
Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
An observational study of Cancer of the Larynx, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cancer of the Larynx
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2014
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 adult patients, ages 35-80 y/o who underwent total laryngectomy and a trechea esophageal puncture was performed for the use of voice prothesis.
Who may be able to join
- patients post total laryngectomy with voice prothesis
Who cannot join
- patients who can not read and respod to questions
Trial locations and contacts
No sites are listed yet.
About this study
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.
Read the detailed description
This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.
- Conditions
- Cancer of the Larynx
- Keywords
- laryngectomy, swallowing disturbances, speech disturbances, speech intelligibility, voice prothesis
- Medical subject headings
- Laryngeal Neoplasms, Speech Disorders, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total laryngectomy | A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech and swallowing characteristics of patients post laryngectomy
After recording the patients' speech the speech characteristics will be analysed according to specific parameters. Also after performing swallowing eveluation swallowing disturbances will be diagnosed and described.
Measured: At the completion of data collection -1 year
Secondary outcomes (1)
The relationship between speech and swallowing disturbances of patients post laryngectomy
After analyzing the speech and swallowing disturbances of patients post laryngectomy, the relationship between these variables will be examined.
Measured: 1 year at the completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the LarynxStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jacob T Cohen, PhD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607138
- Sponsor's protocol ID
- TASMC-12-CTJ-224-CTIL
- Status last verified
- May 2012
- First submitted
- 24 May 2012
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
* Maclean, J., Cotton, S., & Perry, A. (2009). Post-laryngectomy: it's hard to swallow: an Australian study of prevalence and self-reports of swallowing function after a total laryngectomy. Dysphagia, 24(2), 172-179. * Maclean, J., Cotton, S., & Perry, A. (2009). Dysphagia following a total laryngectomy: the effect on quality of life, functioning, and psychological well-being. Dysphagia, 24(3), 314-321. * McHorney, C. A., Robbins, J., Lomax, K., Rosenbek, J. C., Chignell, K., Kramer, A. E., & Bricker, D. E. (2002). The SWAL-QOL and SWAL-CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity. Dysphagia, 17(2), 97-114. * Platteaux, N., Dirix, P., Dejaeger, E., & Nuyts, S. (2010). Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia, 25(2), 139-152. * Kapila,M., Deore,N., Palav,R.S., Kazi,R.A., Shah,R.P., & Jagade,M.V.(2011). A brief review of voice restoration following total laryngectomy. Indian Journal of Cancer,48(1),99-104. * Rizzo,B.p.,Maronato,F.,Marchiori,C., Gava,A., &Da Mosto, M,C.(2008). Long-Term Quality of Life After Total Laryngectomy and Postoperative Radiotherapy Versus Concurrent Chemoradiotherapy for Laryngeal Preservation. The Laryngoscope.118,300-306 (2010). Total Laryngectomy.OtorhinolaryngologyMohebati,A. Mohebati,A & * Shah ,p .j , International Journal, 2(3), pp 207-214
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
- ClinicalTrials.gov ID
- NCT01607138
- Acronym / sponsor ID
- TASMC-12-CTJ-224-CTIL
- Conditions
- Cancer of the Larynx
- Keywords
- laryngectomy, swallowing disturbances, speech disturbances, speech intelligibility, voice prothesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 May 2012 (estimated)
- 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.
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.
Detailed description
This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total laryngectomy | – | –A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 adult patients, ages 35-80 y/o who underwent total laryngectomy and a trechea esophageal puncture was performed for the use of voice prothesis.
Key inclusion criteria (1 listed)
- patients post total laryngectomy with voice prothesis
Key exclusion criteria (1 listed)
- patients who can not read and respod to questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speech and swallowing characteristics of patients post laryngectomy
Time frame: At the completion of data collection -1 year
After recording the patients' speech the speech characteristics will be analysed according to specific parameters. Also after performing swallowing eveluation swallowing disturbances will be diagnosed and described.
1 secondary outcome
The relationship between speech and swallowing disturbances of patients post laryngectomy
Time frame: 1 year at the completion of data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Background* Maclean, J., Cotton, S., & Perry, A. (2009). Post-laryngectomy: it's hard to swallow: an Australian study of prevalence and self-reports of swallowing function after a total laryngectomy. Dysphagia, 24(2), 172-179. * Maclean, J., Cotton, S., & Perry, A. (2009). Dysphagia following a total laryngectomy: the effect on quality of life, functioning, and psychological well-being. Dysphagia, 24(3), 314-321. * McHorney, C. A., Robbins, J., Lomax, K., Rosenbek, J. C., Chignell, K., Kramer, A. E., & Bricker, D. E. (2002). The SWAL-QOL and SWAL-CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity. Dysphagia, 17(2), 97-114. * Platteaux, N., Dirix, P., Dejaeger, E., & Nuyts, S. (2010). Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia, 25(2), 139-152. * Kapila,M., Deore,N., Palav,R.S., Kazi,R.A., Shah,R.P., & Jagade,M.V.(2011). A brief review of voice restoration following total laryngectomy. Indian Journal of Cancer,48(1),99-104. * Rizzo,B.p.,Maronato,F.,Marchiori,C., Gava,A., &Da Mosto, M,C.(2008). Long-Term Quality of Life After Total Laryngectomy and Postoperative Radiotherapy Versus Concurrent Chemoradiotherapy for Laryngeal Preservation. The Laryngoscope.118,300-306 (2010). Total Laryngectomy.OtorhinolaryngologyMohebati,A. Mohebati,A & * Shah ,p .j , International Journal, 2(3), pp 207-214
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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.
Jacob T Cohen, PhD principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Larynx, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob T Cohen, MD (0524266364, jacobc@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech and swallowing characteristics of patients post laryngectomy (time frame: At the completion of data collection -1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607138, which also lists 1 linked publication.
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 28 May 2012.