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Frequency of Xerostomia and Their Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy (XEROSTOMIA)

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ClinicalTrials.gov Identifier: NCT02857413
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

The aim of this study is the evaluation of the frequency of xerostomia and their management after radiotherapy in head and neck cancer.

The quality of life of these patients is also analysed with European Organization for Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).


Condition or disease
Head and Neck Neoplasms

Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Frequency of Xerostomia and Their Care Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Frequency of xerostomia and their management after radiotherapy in head and neck cancer [ Time Frame: at enrollment ]
    patients describe the severity of their xerostomia and their management in a standardized questionnaire


Secondary Outcome Measures :
  1. quality of life af patients after radiotherapy in head and neck cancer [ Time Frame: at enrollment ]
    patients describe their quality of life in a standardized questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with head and neck cancer after radiotherapy treatment
Criteria

Inclusion Criteria:

  • patient with head and neck cancer after radiotherapy treatment

Exclusion Criteria:

  • patient already treated for xerostomia for other reason : Sjögren's syndrome, medication, diabetes,...

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): NCT02857413


Locations
France
CHU Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Edouard Euvrard, MD CHU Besançon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02857413     History of Changes
Other Study ID Numbers: P/2015/281
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Xerostomia
Radiotherapy

Additional relevant MeSH terms:
Xerostomia
Head and Neck Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Neoplasms