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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00995319
First Posted: October 15, 2009
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • salivary flow [ Time Frame: 3 months ]
  • salivary flow [ Time Frame: 12 months ]

Enrollment: 58
Actual Study Start Date: January 2008
Study Completion Date: July 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
radiation patients
cancer patients with radiotherapy concerning the head and neck area/oral cavity

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refused approval
  • survival prognosis under one year
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995319


Locations
Norway
Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Investigators
Study Director: Christoph M Ziegler, Prof.Dr.Dr. St.Olavs Hospital / NTNU
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00995319     History of Changes
Other Study ID Numbers: 17436
First Submitted: October 14, 2009
First Posted: October 15, 2009
Last Update Posted: April 4, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
mouth
Mucositis
Dysphagia
malnutrition
Xerostomia
saliva
tooth injuries

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms