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.

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Key information

Conditions

Head and Neck Cancer Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Neoplasms Malnutrition Mouth Diseases Mucositis Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Salivary Gland Diseases Stomatognathic Diseases Tooth Diseases Tooth Injuries Wounds and Injuries Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

refused approval
survival prognosis under one year

Treatment and study plan

Primary outcomes

salivary flow

Time frame: 3 months
salivary flow

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

Helse Midt-Norge
St. Olavs Hospital

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2014
First posted: Oct 15, 2009
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed