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

January 14, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer. (Original Title in Italian Language: "Il Trattamento Del Carcinoma Laringeo: Outcome Oncologico, Funzionale e Quality of Life")

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (>= 18 years) of both sexes treated and followed for laryngeal cancer at the Department of Otollaryngology and Audiology of the University Hospital of Bologna.

Description

Inclusion Criteria:

  • Patients treated for laryngeal cancer diagnosed by histopathologic examination

Exclusion Criteria:

  • Patients lost at follow up
  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic and functional outcome in patients treated for laryngeal cancer.
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in patients treated for laryngeal cancer.
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Cecilia Botti, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

November 2, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LARYNX2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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