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Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches

This study has been completed.
Sponsor:
Collaborators:
Massachusetts Eye and Ear Infirmary
Brigham and Women's Hospital
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00600223
First received: January 11, 2008
Last updated: October 8, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Larynx Cancer
 Behavioral: questionnaires and standardized, digital voice recording

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients undergoing laryngectomy and pharyngeal reconstruction
 Behavioral: questionnaires and standardized, digital voice recording
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MSKCC clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Do not have functional voice restoration.
  • Do not speak English as a functional language.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600223

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Massachusetts Eye and Ear Infirmary
Brigham and Women's Hospital
Investigators
Principal Investigator: Dennis Kraus, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dennis Kraus, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00600223     History of Changes
Other Study ID Numbers: 05-104
Study First Received: January 11, 2008
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013