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

NCT ID: NCT00995319

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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radiation patients

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refused approval
* survival prognosis under one year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Helse Midt-Norge

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph M Ziegler, Prof.Dr.Dr.

Role: STUDY_DIRECTOR

St.Olavs Hospital / NTNU

Locations

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Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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17436

Identifier Type: -

Identifier Source: org_study_id

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