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

Recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT02489084
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in patient-rated symptoms	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	At 6,12,18,24,36,48,60 months after last day of completion of treatment	Assessed by questionnaires
Change in acute toxicity	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	At 6,12,18,24,36,48,60 months after last day of completion of treatment	Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands