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

Squamous Cell Carcinoma of the Oropharynx Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02552550
• Other study ID #: 1208112
• Secondary ID: 2012-A00904-39
• Status: Terminated
• Start date: July 25, 2013
• Est. completion date: September 20, 2016

Study information

• Verified date: June 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 20, 2016
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of the Oropharynx

Intervention

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.

Locations

Country	Name	City	State
France	CHu de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from phonation disorder	Phonation disorders will be evaluated by the scale "Voice Handicap Index" (composite measure)	between day 0 and 1 year
Secondary	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