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

Primary Purpose

Oral Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quality of life survey/ dental statement
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

oral cancer

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2015
Last Updated
August 10, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02866500
Brief Title
Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study
Acronym
VADS
Official Title
Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral cancer
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Quality of life survey/ dental statement
Intervention Description
Assessment of oral state and patients quality of life before radiotherapy and along treatment for oral cancer
Primary Outcome Measure Information:
Title
Number of changes in pain score using CTCAE v4.0 scale
Description
Units on scales of CTCAE v4.0
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne RASKIN, MD PhD
Phone
+334 86 13 68 68
Email
anne.raskin@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne RASKIN, MD PhD
Email
anne.raskin@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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