Head and Neck NeoplasmsXEROSTOMIANCT02857413
Frequency of Xerostomia and Their Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy
An observational study of Head and Neck Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with head and neck cancer after radiotherapy treatment
Who may be able to join
- patient with head and neck cancer after radiotherapy treatment
Who cannot join
- patient already treated for xerostomia for other reason : Sjögren's syndrome, medication, diabetes,...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Frequency of Xerostomia and Their Care Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy
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).
- Conditions
- Head and Neck Neoplasms
- Keywords
- Xerostomia, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of xerostomia and their management after radiotherapy in head and neck cancer
patients describe the severity of their xerostomia and their management in a standardized questionnaire
Measured: at enrollment
Secondary outcomes (1)
quality of life af patients after radiotherapy in head and neck cancer
patients describe their quality of life in a standardized questionnaire
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Euvrard, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857413
- Sponsor's protocol ID
- P/2015/281
- Acronym
- XEROSTOMIA
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frequency of Xerostomia and Their Care Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy
- ClinicalTrials.gov ID
- NCT02857413
- Acronym / sponsor ID
- XEROSTOMIA / P/2015/281
- Conditions
- Head and Neck Neoplasms
- Keywords
- Xerostomia, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with head and neck cancer after radiotherapy treatment
Key inclusion criteria (1 listed)
- patient with head and neck cancer after radiotherapy treatment
Key exclusion criteria (1 listed)
- patient already treated for xerostomia for other reason : Sjögren's syndrome, medication, diabetes,...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
quality of life af patients after radiotherapy in head and neck cancer
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Euvrard, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of xerostomia and their management after radiotherapy in head and neck cancer (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.