H&N Cancer; Survivorship and Late Effects

Survivorship and Late Effects in Head and Neck Cancer Survivors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04758026

Enrollment

265

Registered

2021-02-17

Start date

2018-10-10

Completion date

2020-10-10

Last updated

2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms, Survivorship

Keywords

Patient Reported Outcome Measure, Quality of Life, Head and Neck Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires	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

Measure	Time frame	Description
Risk factors for late effects after head and neck cancer treatement	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

Countries

Norway

Outcome results