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
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||Phase|
|Cancer: Head or Neck||Procedure: IMRT versus conventional radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Procedure: IMRT versus conventional radiotherapy
Comparing MRT versus conventional radiotherapy
- Volume of saliva [ Time Frame: 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) ]
- Oral flora [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ]
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
|Contact: Roeland De Moor, MD, PhDfirstname.lastname@example.org|
|University Hospital Ghent||Recruiting|
|Ghent, Belgium, 9000|
|Contact: Roeland De Moor, MD, PhD roeland.demoor@UGent.be|
|Principal Investigator: Roeland De Moor, MD, PhD|
|Principal Investigator:||Roeland De Moor, MD, PhD||University Hospital, Ghent|