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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Squamous Cell Carcinoma of the Oropharynx

Intervention / Treatment
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* Procedure: Ability to swallow, speak and quality of life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ability to swallow, speak and quality of life<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from swallowing disorder | 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 | Phonation disorders will be evaluated by the scale Voice Handicap Index (composite measure) | between day 0 and 1 year | 
| Change from quality of life | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma of the oropharynx, swallowing, speech, quality of life