NCT00323466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 5, 2006

Last Update Submit

May 8, 2023

Conditions

Cancer: Head or Neck

Outcome Measures

Primary Outcomes (3)

  • Volume of saliva

    Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

  • Quality of saliva

    Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

  • Oral flora

    Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

Study Arms (1)

IMRT

EXPERIMENTAL
Procedure: IMRT versus conventional radiotherapy

Interventions

IMRT versus conventional radiotherapyPROCEDURE

Comparing MRT versus conventional radiotherapy

IMRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • Cancer of head or neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Roeland De Moor, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

BE(1)