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 January 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
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
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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 |
Resource links provided by NLM:
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
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013