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.
Study Type
OBSERVATIONAL
Enrollment
2,000
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGChange in acute toxicity
Dysphagia; mucositis; salivary dysfunction; xerostomia
Time frame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Change in late toxicity
Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism
Time frame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Change in patient-rated symptoms
Assessed by questionnaires
Time frame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Change in patient-rated Quality-of-Life
Assessed by questionnaires
Time frame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
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