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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
This study is currently recruiting participants.
Verified by University Hospital, Ghent, December 2007
Sponsors and Collaborators: University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323466
  Purpose

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.


Condition Intervention
Cancer: Head or Neck
Procedure: IMRT versus conventional radiotherapy

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Volume of saliva
  • Quality of saliva
  • Oral flora

Estimated Enrollment: 40
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • Cancer of head or neck

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323466

Contacts
Contact: Geert Hommez, MD 0032/(0)9/240.48.04 geert.hommez@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Geert Hommez, MD     0032(0)9/240.48.04     geert.hommez@UGent.be    
Principal Investigator: Geert Hommez, MD            
Sponsors and Collaborators
University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Geert Hommez, MD University Hospital, Ghent
  More Information

Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2006/164
Study First Received: May 5, 2006
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00323466  
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Head and Neck Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009