Clinical Trials Directory

Trials / Completed

CompletedNCT04758026

H&N Cancer; Survivorship and Late Effects

Survivorship and Late Effects in Head and Neck Cancer Survivors

Status
Completed
Phase
Study type
Observational
Enrollment
265 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Timeline

Start date
2018-10-10
Primary completion
2020-10-10
Completion
2020-10-10
First posted
2021-02-17
Last updated
2024-01-03

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04758026. Inclusion in this directory is not an endorsement.