CompletedNot Applicable

Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)

Netherlands2,000 participantsStarted 2013-09

Plain-language summary

Background of the study: Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available. Objective of the study: The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological proven head and neck cancer * Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands * Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment * Northern European ethnicity (ethnicity is a known confounder in SNP association studies) * Willing and able to comply with the study prescriptions * 18 years or older * No prior radiation (in the head and neck area) * Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information * Have given written informed consent before patient registration Exclusion Criteria: * Prior radiotherapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in acute toxicity

Timeframe: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy

Change in late toxicity

Timeframe: At 6,12,18,24,36,48,60 months after last day of completion of treatment

Change in patient-rated symptoms

Timeframe: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy

Change in patient-rated Quality-of-Life

Timeframe: At 6,12,18,24,36,48,60 months after last day of completion of treatment

Trial details

NCT IDNCT02489084

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Head and Neck Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in acute toxicity

Timeframe: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy

Change in late toxicity

Timeframe: At 6,12,18,24,36,48,60 months after last day of completion of treatment

Change in patient-rated symptoms

Timeframe: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy

Change in patient-rated Quality-of-Life

Timeframe: At 6,12,18,24,36,48,60 months after last day of completion of treatment