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

Larynx Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600223
• Other study ID #: 05-104
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: October 8, 2010
• Start date: October 2005
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Larynx Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Brigham and Women's Hospital, Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		conclusion of study	No
Secondary	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.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center