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. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
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: January 29, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
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) ] [ Designated as safety issue: No ]
  • Quality of saliva [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ] [ Designated as safety issue: No ]
  • Oral flora [ Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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
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
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:
No publications provided

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: January 29, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014