Back to resultsA 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
Primary Purpose
Cancer: Head or Neck
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
IMRT versus conventional radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cancer: Head or Neck
Eligibility Criteria
Inclusion Criteria: > 18 years old Cancer of head or neck Exclusion Criteria: -
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMRT
Arm Description
Outcomes
Primary Outcome Measures
Volume of saliva
Quality of saliva
Oral flora
Secondary Outcome Measures
Full Information
NCT ID
NCT00323466
First Posted
May 5, 2006
Last Updated
May 8, 2023
Sponsor
University Hospital, Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00323466
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2007 (Actual)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer: Head or Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMRT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
IMRT versus conventional radiotherapy
Intervention Description
Comparing MRT versus conventional radiotherapy
Primary Outcome Measure Information:
Title
Volume of saliva
Time Frame
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Title
Quality of saliva
Time Frame
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Title
Oral flora
Time Frame
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years old
Cancer of head or neck
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roeland De Moor, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
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
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