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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 5, 2006

Last Updated Date

January 29, 2013

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Volume of saliva
Quality of saliva
Oral flora

Change History

Complete list of historical versions of study NCT00323466 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer: Head or Neck

Intervention ^ICMJE

Procedure: IMRT versus conventional radiotherapy

Comparing MRT versus conventional radiotherapy

Study Arm (s)

Experimental: IMRT

Intervention: Procedure: IMRT versus conventional radiotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

> 18 years old
Cancer of head or neck

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roeland De Moor, MD, PhD

roeland.demoor@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00323466

Other Study ID Numbers ^ICMJE

2006/164

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Fund for Scientific Research, Flanders, Belgium

Investigators ^ICMJE

Principal Investigator:

Roeland De Moor, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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