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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323466
First received: May 5, 2006
Last updated: December 4, 2014
Last verified: December 2014
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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) ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT Procedure: IMRT versus conventional radiotherapy
Comparing MRT versus conventional radiotherapy

  Eligibility

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323466     History of Changes
Other Study ID Numbers: 2006/164
Study First Received: May 5, 2006
Last Updated: December 4, 2014

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

ClinicalTrials.gov processed this record on April 28, 2017