Head and Neck NeoplasmsNCT04758026
H&N Cancer; Survivorship and Late Effects
An observational study of Head and Neck Neoplasms and Survivorship, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Survivorship
- How many people
- 265 participants
- Where
- 1 siteNorway
- Study dates
- 10 Oct 2018to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HNC survivors treated at OUH in the period from 2006 to 2012 are eligible.
Who may be able to join
- 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
Who cannot join
- Unwillingness to answer HRQL questionnaires
- Patients under ongoing treatment for secondary cancer or relapse at the time of the survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Survivorship
- Keywords
- Patient Reported Outcome Measure, Quality of Life, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2022
Secondary outcomes (1)
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
Measured: June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start10 Oct 2018
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Cecilie Delphin Amdal, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758026
- Sponsor's protocol ID
- 2018-21
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Late Effects in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT04758026
- Acronym / sponsor ID
- 2018-21
- Conditions
- Head and Neck Neoplasms, Survivorship
- Keywords
- Patient Reported Outcome Measure, Quality of Life, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HNC survivors treated at OUH in the period from 2006 to 2012 are eligible.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unwillingness to answer HRQL questionnaires
- Patients under ongoing treatment for secondary cancer or relapse at the time of the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Risk factors for late effects after head and neck cancer treatement
Time frame: June 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Survivorship, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires (time frame: June 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.