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Trial record 6 of 165 for:    "Lip and oral cavity cancer"

Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study (VADS)

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ClinicalTrials.gov Identifier: NCT02866500
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Context: the oral cancer is the 5th cancer in order of frequency for human in France. It is the country where the mortality by oral cancer is the most raised in Europe. The most frequent location concerns the oral cavity prevalency of which is one of higher in the world. The main risk factors are the tobacco and the alcohol.

The oral cancer is treated in the great majority of the cases by radiotherapy which is going to pull xerostomy, responsible for the degradation of the oral state. Furthermore, it will increase the risk of appearance of osteoradionecrosis (ORN) when the patient is carrier of buccal lesions and\or when he will have to undergo surgical acts. Consequently, the initial oral state of the patients is to be estimated so as to eliminate any source of the infection. An unfavourable initial state will increase the risk of degradation of this one and appearance of ORN. However, at present few epidemiological data are available concerning the oral state of the patients presenting an oral cancer.

Objective: the main objective of this study is to describe, before radiotherapy, the oral state of the patients presenting an oral cancer and to follow the evolution of this oral state for three years and to register the patients quality of life. The secondary objectives are to describe the distribution of risk factors of the degradation of the oral state (oral hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and to register the impact of the dental restorations on the radiological assessment.

Methods: this prospective epidemiological study of observation will be realized in the service of odontology of the Timone hospital (Marseille, France) in association with the services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy and medical oncology of Timone and Paoli Calmettes institute (IPC). All the toothed patients affected by an oral cancer untreated will be included, or treated surgically only, of more than 18 years old and for whom an initial dental assessment will be realized. The main assessment criteria will be the CAD index and the parodontal state.

Expected results and perspectives: This study will allow to have epidemiological data concerning patients' oral state affected by an oral cancer before and after radiotherapy. It will allow to set up a consensus of good practice.


Condition or disease Intervention/treatment Phase
Oral Cancer Behavioral: Quality of life survey/ dental statement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: oral cancer Behavioral: Quality of life survey/ dental statement
Assessment of oral state and patients quality of life before radiotherapy and along treatment for oral cancer




Primary Outcome Measures :
  1. Number of changes in pain score using CTCAE v4.0 scale [ Time Frame: 6 Weeks ]
    Units on scales of CTCAE v4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a first oral cancer
  • Patient with teeth
  • Patient not yet treated for the oral cancer

Exclusion Criteria:

  • Patient with a cancer already treated or with an oral cancer ongoing treatment.
  • Patient without teeth
  • Patient with trouble for comprehention and without capabilities for brushing teeth

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): NCT02866500


Contacts
Contact: Anne RASKIN, MD PhD +334 86 13 68 68 anne.raskin@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Anne RASKIN, MD PhD       anne.raskin@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866500     History of Changes
Other Study ID Numbers: 2014-02
2014-A01244-43 ( Other Identifier: Ansm )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases