NCT02857413

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

August 2, 2016

Last Update Submit

August 4, 2016

Conditions

Head and Neck Neoplasms

Keywords

XerostomiaRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    at enrollment

Secondary Outcomes (1)

  • quality of life af patients after radiotherapy in head and neck cancer

    at enrollment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with head and neck cancer after radiotherapy treatment

You may qualify if:

  • patient with head and neck cancer after radiotherapy treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsXerostomia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Edouard Euvrard, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 5, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)