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

NCT ID: NCT02552550

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-25

Study Completion Date

2016-09-20

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.

Conditions

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Squamous Cell Carcinoma of the Oropharynx

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ability to swallow, speak and quality of life

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel PRADES, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHu de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00904-39

Identifier Type: OTHER

Identifier Source: secondary_id

1208112

Identifier Type: -

Identifier Source: org_study_id

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