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

Terminated

• Conditions: Squamous Cell Carcinoma of the Oropharynx
• Interventions: Procedure: Ability to swallow, speak and quality of life

• Registration Number: NCT02552550
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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 Timeline

• Study Start: 2013-07-25
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2016-09-20
• Study Completion: 2016-09-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ability to swallow, speak and quality of life	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.

Primary Outcome Measures

Name	Time	Method
change from swallowing disorder	between day 0 and 1 year	A swallowing disorder will be determined by conducting a video-endoscopy and voluntary swallowing reflex (composite measure)

Secondary Outcome Measures

Name	Time	Method
Change from phonation disorder	between day 0 and 1 year	Phonation disorders will be evaluated by the scale "Voice Handicap Index" (composite measure)
Change from quality of life	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)

Trial Locations

Locations (1)

CHu de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France