A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck
May 8, 2023 updated by: University Hospital, Ghent
Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus conventional radiotherapy.
In each group, one part will receive normal dental preventive treatment. The other part will use products for treatment of dry mouth (Biotene gamma).
Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- > 18 years old
- Cancer of head or neck
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IMRT
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Comparing MRT versus conventional radiotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Volume of saliva
Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
|
Quality of saliva
Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
|
Oral flora
Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Roeland De Moor, MD, PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
May 5, 2006
First Submitted That Met QC Criteria
May 5, 2006
First Posted (Estimate)
May 9, 2006
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.