H&N Cancer; Survivorship and Late Effects

Survivorship and Late Effects in Head and Neck Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Survivorship

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.

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, N-0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HNC survivors treated at OUH in the period from 2006 to 2012 are eligible.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Quality of Life; Patient Reported Outcome Measure
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2018-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from 50-100 of the participants will be included in the EORTC 1629 - Late toxicity and long-term quality of life in head and neck cancer survivors
• IPD Sharing Time Frame: 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No