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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Number of changes in pain score using CTCAE v4.0 scale


Condition

Oral Cancer

Intervention

Quality of life survey/ dental statement

Study Arms / Comparison Groups

 oral cancer
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

150

Start Date

January 2015

Completion Date

January 2019

Primary Completion Date

January 2018

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Urielle DESALBRES, +334 86 13 68 68, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02866500

Organization ID

2014-02

Secondary IDs

2014-A01244-43

Responsible Party

Sponsor

Study Sponsor

Assistance Publique Hopitaux De Marseille


Study Sponsor

Urielle DESALBRES, Study Director, Assistance Publique Hôpitaux de Marseille


Verification Date

August 2016