H&N Cancer; Survivorship & Late Effects

Status Completed

Clinical Trial Summary

A cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (HNC). Participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.

Clinical Trial Description

The purpose of this study is to provide knowledge on late effects and mortality risk after modern treatment in long-term survivors of head and neck cancer (HNC). This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients. For head and neck cancer (HNC) survivors of today, with the rising proportion of HPV induced cancer and with improved modern treatment, the late effects and mortality risk has changed compared to survivors previous decades. The investigators will assess the prevalence and severity of a broad range of late effects and identify associated risk factors for the following late effects; - Chronic fatigue - Hearing loss and tinnitus - Oral late effects, including taste and smell disturbances and osteoradionecrosis - Dysphagia and malnutrition - Body image, intimacy and endocrine dysfunction In addition,possible biological explanatory mechanisms for fatigue and possibly other selected late effects will be explored. Data will be compared to age and gender matched reference data for those where this is available. Design: a cross-sectional study Assessments: Patient-reported questionnaires, blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04758026
Study type	Observational
Source	Oslo University Hospital
Contact
Status	Completed
Phase
Start date	October 10, 2018
Completion date	October 10, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

H&N Cancer; Survivorship and Late Effects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms