Clinical trial NCT04758026: H&N Cancer; Survivorship and Late Effects
Official title: Survivorship and Late Effects in Head and Neck Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Survivorship
Keywords: Patient Reported Outcome Measure
Quality of Life
Head and Neck Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2021-02-17
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HNC survivors treated at OUH in the period from 2006 to 2012 are eligible.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires
timeFrame: June 2022
Secondary outcomes:
measure: Risk factors for late effects after head and neck cancer treatement
timeFrame: June 2022
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: