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

May 8, 2023 updated by: University Hospital, Ghent

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 18 years old
  • Cancer of head or neck

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT
Procedure: IMRT versus conventional radiotherapy
Comparing MRT versus conventional radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of saliva
Time Frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
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)
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)
Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: Roeland De Moor, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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