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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04758026
Other study ID # 2018-21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2018
Est. completion date October 10, 2020

Study information

Verified date December 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date October 10, 2020
Est. primary completion date October 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0 - C06.9; C07; C08.0 - C08.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9, C77.0 - Diagnosed 2006- 2012 - Ability to understand and respond to the questionnaires - Ability to attend the clinical examination - Informed consent received Exclusion Criteria: - Unwillingness to answer HRQL questionnaires - Patients under ongoing treatment for secondary cancer or relapse at the time of the survey

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires Assess prevalence of fatigue, dysphagia, xerostomia, hearing problems, oral health, body image and intimacy in surivors of head and neck cancer more than 5 years after treatment. Patients filled in a set of patient-reported questionnaires: 1) EORTC core quality of life questionnaire, the EORTC QLQ-C30 version 3, 2) EORTC disease specific module, the EORTC QLQ-H&N35 3) The Fatigue Questionnaire, 4) The scale for chemotherapy induced neurotoxicity (SCIN), 5) EORTC-QLQ-OH15, 6) Body image scale. June 2022
Secondary Risk factors for late effects after head and neck cancer treatement to explore associated risk factors for fatigue, dysphagia, xerostomia, hearing problems, oral health in surivors of head and neck cancer more than 5 years after treatment June 2022
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