Skip to main content
OpenTrials
Completed

NCT Number: NCT04758026

H&N Cancer; Survivorship and Late Effects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires

    Time frame: June 2022

    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.

Secondary outcomes

  1. Risk factors for late effects after head and neck cancer treatement

    Time frame: June 2022

    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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Survivorship and Late Effects in Head and Neck Cancer Survivors

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2021
Registry last updated
Jan 3, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.