Cancer: Head or Neck Clinical Trial
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
| NCT number | NCT00323466 |
| Other study ID # | 2006/164 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2007 |
| Est. completion date | February 2008 |
| Verified date | May 2023 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | February 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - > 18 years old - Cancer of head or neck Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Fund for Scientific Research, Flanders, Belgium |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Volume of saliva | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) | ||
| Primary | Quality of saliva | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) | ||
| Primary | Oral flora | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) |