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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

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ClinicalTrials.gov Identifier: NCT00323466
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : May 9, 2006
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent

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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: IMRT Procedure: IMRT versus conventional radiotherapy
Comparing MRT versus conventional radiotherapy



Primary Outcome Measures :
  1. Volume of saliva [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ]
  2. Quality of saliva [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ]
  3. Oral flora [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • Cancer of head or neck

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323466


Contacts
Contact: Roeland De Moor, MD, PhD roeland.demoor@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Roeland De Moor, MD, PhD       roeland.demoor@UGent.be   
Principal Investigator: Roeland De Moor, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Roeland De Moor, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323466     History of Changes
Other Study ID Numbers: 2006/164
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms