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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Primary outcomes

Change in acute toxicity

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

Dysphagia; mucositis; salivary dysfunction; xerostomia
Change in late toxicity

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

Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism
Change in patient-rated symptoms

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

Assessed by questionnaires
Change in patient-rated Quality-of-Life

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

Assessed by questionnaires

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: HANS

Important dates

Study start: 2013
Primary completion: 2026
Study completion: 2026
First posted: Jul 2, 2015
Registry last updated: Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed