Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)

Speech Disorders Clinical Trial

Official title:

Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489965
• Other study ID #: UCDavis-1509981-2
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: Jasmine Cate
• Phone: 8582463035
• Email: jcate[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To perform a multi-site prospective study assessing, both subjectively and objectively, the gender disparities in speech outcomes of patients using TEP after total laryngectomy. The investigators hypothesize that speech outcomes, both subjective and objective measures, will be significantly poorer for female patients compared to male patients. The outcome of the study is to prospectively assess both subjective and objective gender disparities in voice and speech outcomes of patients using TEP after total laryngectomy across a multiple institutions. The investigators hypothesize that both subjective and objective measurements of voice, speech and quality of life will be poorer for female patients in comparison to male patients.

Description:

Total laryngectomy (TL) is typically performed in patients with advanced laryngeal cancer as a means of removing the entire larynx and surrounding structures that have been affected by the malignancy. Following total laryngectomy, patients lose ability to produce voice. Thus, they require the use of alternative methods of to produce voice along with extensive speech rehabilitation. Currently, there are three main speech alternative options, esophageal speech, tracheoesophageal speech, and electrolarynx speech. The focus of this study will be on patients rehabilitating their speech using tracheosophgeal speech through a tracheoesophageal prosthesis (TEP). It has been shown that generally for TL patients, better voice quality and satisfaction with voice is associated with improved quality of life. Currently, speech rehabilitation outcomes are measured with a multidimensional approach, using various scales ranging from acoustic analysis, perceptual evaluation, and patient-reported outcomes. The majority of studies analyzing outcomes in total laryngectomy patients, however, is predominated by assessment of the male laryngectomee population. Historically, this has been due to the greater incidence of laryngeal cancers in males than females. Due to this, there has been minimal research investigating potential gender differences in the laryngectomy population. Of the limited data available regarding the female laryngectomee population, it has been shown that gender frequency differences seen in normal subjects are lost following total laryngectomy and the resulting tracheoesophageal voice is more similar to the normal male voice, thus females face a greater voice handicap compared to their male counterparts (Kazi, 2006; Deore, 2011). While some studies have assessed the resulting quality of life differences between the genders in the laryngectomy population (Lee, 2010), few have investigated voice outcomes using both subjective and objective scales as used in this study. The outcomes of this study will be key to understanding what metrics are potentially contributing to the voice and lifestyle dissatisfaction that prior studies have demonstrated in the female laryngectomee population. This quantifiable data will provide a way of modifying future voice rehabilitation in the female population to enable better satisfaction and minimize gender differences in voice outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects who have completed total laryngectomy and are using TEP

Exclusion Criteria:

• Subjects who have not completed total laryngectomy and are not using TEP

Related Conditions & MeSH terms

• Laryngectomy; Status
• Speech Disorders
• Speech Dysfunction
• Total Laryngectomy

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)	Patient reported survey.	Through study completion; 3 years (anticipate completion by June 2025)
Primary	AVHI (Alaryngeal Voice Handicap Index)	Patient reported survey.	Through study completion; 3 years (anticipate completion by June 2025)
Secondary	GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain	Examiner-based interpretation of roughness/breathiness of patient's voice. Scale of 0-3, 3 indicating severe, 0 indicating normal	Through study completion; 3 years (anticipate completion by June 2025)
Secondary	Sustained phonation time	A measurement in seconds of how long a patient can sustain phonation.	Through study completion; 3 years (anticipate completion by June 2025)
Secondary	Fundamental frequency	A measurement of frequency of voice during alaryngeal speech/sustained phonation	Through study completion; 3 years (anticipate completion by June 2025)