Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02552550
Recruitment Status : Terminated (rate of inclusion too low)
First Posted : September 17, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Oropharynx Procedure: Ability to swallow, speak and quality of life

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 25, 2013
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2016
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patietn with T3 or T4 stage squamous cell cancer of the oropharynx
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552550


Locations
Layout table for location information
France
CHu de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Jean-Michel PRADES, MD PhD CHU de SAINT-ETIENNE
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02552550    
Other Study ID Numbers: 1208112
2012-A00904-39 ( Other Identifier: ANSM )
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
squamous cell carcinoma of the oropharynx
swallowing, speech
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases