Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer

Active, not recruiting

• Conditions: Laryngeal Cancer

• Registration Number: NCT06784401
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer.

Detailed Description

Adult (\>=18 years of age) patients treated by surgery and/or radiation therapy are enrolled retrospectively.

The main question it aims to answer is:

Is voice after total laryngectomy with voice prosthesis better than voice after open partial horizzontal laryngectomy? Subjective and objective scales and parameters are used.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-09-01
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-11-02
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients treated for laryngeal cancer diagnosed by histopathologic examination

Exclusion Criteria

• Patients lost at follow up
• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncologic and functional outcome in patients treated for laryngeal cancer.	through study completion, an average of 1 year	Compare the functional phonatory outcome assessed through objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing total laryngectomy with placement of phonatory prosthesis with patients undergoing partial laryngectomy.; Compare the functional phonatory outcome assessed by objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing microlaryngoscopy cordectomy with patients undergoing exclusive radiotherapy for glottic cancer.; Identify and describe phonation patterns in patients undergoing laryngectomy partial laryngectomy, evaluating possible associations between phonation patterns and phonatory outcomes.

Secondary Outcome Measures

Name	Time	Method
Quality of life in patients treated for laryngeal cancer.	through study completion, an average of 1 year	To compare the quality of life and voice rate of satisfaction by subjective questionnaires (Voice Handicap Index - 10 and I-SECEL) in patients undergoing the different surgical techniques.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy