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CompletedNCT00995319Updated Apr 4, 2017

Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

An observational study in Head and Neck Cancer, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Norwegian University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.

Read the detailed description

The "Dental Team" at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • mouth
  • Mucositis
  • Dysphagia
  • malnutrition
  • Xerostomia
  • saliva
  • tooth injuries
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 58 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All cancer patients with radiation therapy concerning the oral cavity who are in care of the Detal Team at St.Olavs University Hospital

Inclusion criteria

  • radiation concerning the oral cavity
  • follow-up at the Dental Team

Exclusion criteria

Exclusion Criteria:

  • refused approval
  • survival prognosis under one year
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)

Groups and cohorts

  • radiation patients

    cancer patients with radiotherapy concerning the head and neck area/oral cavity

06

What researchers measure

Primary outcomes

  1. salivary flow

    Time frame: 3 months

  2. salivary flow

    Time frame: 12 months

07

Study locations

1 site
  • Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU
    Trondheim, 7006, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00995319
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Midt-Norge
Responsible party
Sponsor
First posted
Oct 15, 2009
Start date
Jan 2008
Primary completion
Jan 2013
Completion
Jul 2014
Last update
Apr 4, 2017

Study contacts

Christoph M Ziegler, Prof.Dr.Dr.
study director · St.Olavs Hospital / NTNU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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