Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches - Full Text View

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

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (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

Contacts


Contact: Dennis Kraus, MD		krausd@mskcc.org

Contact: Ryan Branski, PhD		branskir@mskcc.org

Locations


United States, New York
	Memorial Sloan Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: Dennis Kraus, MD krausd@mskcc.org
	Contact: Ryan Branski, PhD branskir@mskcc.org
	Principal Investigator: Dennis Kraus, MD

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

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

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Dennis Kraus, MD )
Study ID Numbers:	05-104
First Received:	January 11, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00600223
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases

Head and Neck Neoplasms

Laryngeal carcinoma

Laryngeal Neoplasms

Laryngeal Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Massachusetts Eye and Ear Infirmary Brigham and Women's Hospital
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00600223