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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00995319
First received: October 14, 2009
Last updated: January 5, 2012
Last verified: January 2012
History of Changes

October 14, 2009
January 5, 2012
January 2008
September 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00995319 on ClinicalTrials.gov Archive Site
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Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area
Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

All cancer patients with radiation therapy concerning the oral cavity who are in care of the Detal Team at St.Olavs University Hospital
  • Mucositis of the Oral Mucosa
  • Dysphagia With Malnutrition
  • Xerostomia With Decreased Saliva Flow and Dental Defects
Not Provided
radiation patients
cancer patients with radiotherapy concerning the head and neck area/oral cavity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
September 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • refused approval
  • survival prognosis under one year
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00995319
17436
Yes
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • Helse Midt-Norge
Study Director: Christoph M Ziegler, Prof.Dr.Dr. St.Olavs Hospital / NTNU
Norwegian University of Science and Technology
January 2012

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