Larynx CancerNCT00600223
Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches
An observational study of Larynx Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube. The study is evaluating which type of surgery provides patients with the best speech and voice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Cancer
- What is being tested?
- questionnaires and standardized, digital voice recording
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinic
Who may be able to join
- Subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. There is no time frame for reconstruction. All subjects who have previously undergone reconstruction are eligible.
- Subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique.
- > or equal to 18 years old
Who cannot join
- Do not have functional voice restoration.
- Do not speak English as a functional language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches
The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube.
The study is evaluating which type of surgery provides patients with the best speech and voice.
These data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. Information about disease, its treatment, quality of life, and physical and vocal function will be collected. An audio recording of vocal tasks will also be done. All of this information will be analyzed and the two different subject groups will be compared to see if there are differences.
- Conditions
- Larynx Cancer
- Being tested
- questionnaires and standardized, digital voice recording
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires and standardized, digital voice recordingBehavioural
Patient will be asked to complete four sets of forms. Upon completion of these forms, the study subject and the investigator will proceed to a quiet room for the standardized, digital voice recording. Recording will be made on digital audiotape using a standardized portable, digital audio recorder.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing laryngectomy and pharyngeal reconstruction Receives: Behavioral: questionnaires and standardized, digital voice recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the pertinent differences in objective and subjective voice parameters between PR techniques, specifically comparing those techniques that provide mucosal lining (jejunum) to those with cutaneous lining (radial forearm flap).
Measured: conclusion of study
Secondary outcomes (1)
Provide physician with meaningful and relevant data upon which to base the optimal choice of pharyngeal reconstruction method for individual patients who must undergo laryngectomy with pharyngeal reconstruction for the treatment of carcinoma.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, Brigham and Women's Hospital
- Investigators
- Dennis Kraus, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600223
- Sponsor's protocol ID
- 05-104
- Status last verified
- Oct 2010
- First submitted
- 11 Jan 2008
- Last updated
- 11 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches
- ClinicalTrials.gov ID
- NCT00600223
- Acronym / sponsor ID
- 05-104
- Conditions
- Larynx Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, Brigham and Women's Hospital
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jan 2008 (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.
The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube.
The study is evaluating which type of surgery provides patients with the best speech and voice.
These data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. Information about disease, its treatment, quality of life, and physical and vocal function will be collected. An audio recording of vocal tasks will also be done. All of this information will be analyzed and the two different subject groups will be compared to see if there are differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnaires and standardized, digital voice recordingPatients undergoing laryngectomy and pharyngeal reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinic
Key inclusion criteria (3 listed)
- Subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. There is no time frame for reconstruction. All subjects who have previously undergone reconstruction are eligible.
- Subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique.
- > or equal to 18 years old
Key exclusion criteria (2 listed)
- Do not have functional voice restoration.
- Do not speak English as a functional language.
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 |
|---|---|---|
| questionnaires and standardized, digital voice recordingPatient will be asked to complete four sets of forms. Upon completion of these forms, the study subject and the investigator will proceed to a quiet room for the standardized, digital voice recording. Recording will be made on digital audiotape using a standardized portable, digital audio recorder. | Behavioural | 1 |
Primary outcome
Determine the pertinent differences in objective and subjective voice parameters between PR techniques, specifically comparing those techniques that provide mucosal lining (jejunum) to those with cutaneous lining (radial forearm flap).
Time frame: conclusion of study
1 secondary outcome
Provide physician with meaningful and relevant data upon which to base the optimal choice of pharyngeal reconstruction method for individual patients who must undergo laryngectomy with pharyngeal reconstruction for the treatment of carcinoma.
Time frame: conclusion of study
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 11 Oct 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Dennis Kraus, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Larynx Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 2 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 11 Oct 2010. 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 United States. 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?
Determine the pertinent differences in objective and subjective voice parameters between PR techniques, specifically comparing those techniques that provide mucosal lining (jejunum) to those with cutaneous lining (radial forearm flap). (time frame: conclusion of study). 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 11 Oct 2010.