Cancer: Head or NeckNCT00323466
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
A study testing IMRT versus conventional radiotherapy in people with Cancer: Head or Neck, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer: Head or Neck
- What is being tested?
- IMRT versus conventional radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- May 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- Cancer of head or neck
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer: Head or Neck
- Being tested
- IMRT versus conventional radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT versus conventional radiotherapyProcedure or surgery
Comparing MRT versus conventional radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Experimental | Not described Receives: Procedure: IMRT versus conventional radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of saliva
Measured: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Quality of saliva
Measured: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Oral flora
Measured: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer: Head or NeckStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Roeland De Moor, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323466
- Sponsor's protocol ID
- 2006/164
- Status last verified
- May 2023
- First submitted
- 5 May 2006
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00323466
- Acronym / sponsor ID
- 2006/164
- Conditions
- Cancer: Head or Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- May 2007 (actual)
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT | Experimental | Procedure: IMRT versus conventional radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years old
- Cancer of head or neck
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRT versus conventional radiotherapyComparing MRT versus conventional radiotherapy | Procedure or surgery | IMRT |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roeland De Moor, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT versus conventional radiotherapy in people with Cancer: Head or Neck, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of saliva (time frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.