Head and Neck Neoplasms Clinical Trial
Official title:
Survivorship and Late Effects in Head and Neck Cancer Survivors
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 |
Verified date | December 2023 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | University of Oslo |
Norway,
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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