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

Recruiting

• Conditions: Speech Dysfunction; Tracheoesophageal Prosthesis; Laryngectomy; Status; Total Laryngectomy; Speech Disorders

• Registration Number: NCT05489965
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2023-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AVHI (Alaryngeal Voice Handicap Index)	Through study completion; 3 years (anticipate completion by June 2025)	Patient reported survey.
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)	Through study completion; 3 years (anticipate completion by June 2025)	Patient reported survey.

Secondary Outcome Measures

Name	Time	Method
GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain	Through study completion; 3 years (anticipate completion by June 2025)	Examiner-based interpretation of roughness/breathiness of patient's voice. Scale of 0-3, 3 indicating severe, 0 indicating normal
Fundamental frequency	Through study completion; 3 years (anticipate completion by June 2025)	A measurement of frequency of voice during alaryngeal speech/sustained phonation
Sustained phonation time	Through study completion; 3 years (anticipate completion by June 2025)	A measurement in seconds of how long a patient can sustain phonation.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States