Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx

June 1, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent

The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.

The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak then, as in normal practice, after 3, 6 and 12 months after treatment.

Study Type

Observational

Enrollment (Actual)

12

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

  • France
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patietn with T3 or T4 stage squamous cell cancer of the oropharynx

Description

Inclusion Criteria:

  • Patient with stage T3 or T4 squamous cell carcinoma of the oropharynx previously untreated.
  • Performance status 0 or 1
  • Tumor histology proving squamous cell carcinoma

Exclusion Criteria:

  • Visceral metastases at initial assessment
  • Contraindication to surgery and / or chemotherapy such as:
  • A history of other cancer (except basal cell carcinoma skin or cervical cancer in situ)
  • 2nd associated cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ability to swallow, speak and quality of life
This will just be an evaluation, before any treatment, his ability to swallow, speak and quality of life then, as in normal practice, after 3, 6 and 12 months after treatment.
Procedure: Ability to swallow, speak and quality of life
This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak, then his quality of life, as in normal practice, after 3, 6 and 12 months after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from swallowing disorder
Time Frame: between day 0 and 1 year
A swallowing disorder will be determined by conducting a video-endoscopy and voluntary swallowing reflex (composite measure)
between day 0 and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from phonation disorder
Time Frame: between day 0 and 1 year
Phonation disorders will be evaluated by the scale "Voice Handicap Index" (composite measure)
between day 0 and 1 year
Change from quality of life
Time Frame: between day 0 and 1 year
The quality of life will be assessed by the Quality of Life scale EORTC QLQ-C30 and QLC-HN35 (composite measure)
between day 0 and 1 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Jean-Michel PRADES, MD PhD, CHU de Saint-Etienne

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)

July 25, 2013

Primary Completion (ACTUAL)

September 20, 2016

Study Completion (ACTUAL)

September 20, 2016

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (ESTIMATE)

September 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208112
  • 2012-A00904-39 (OTHER: ANSM)

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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