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

Head and Neck Cancer Clinical Trial

— HANS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489084
• Other study ID #: RT2011-03
• Status: Recruiting
• Start date: September 2013
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: A.P.G. Crijns, Dr.
• Phone: +31503610039
• Email: a.p.g.crijns[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Blood sampling

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in acute toxicity	Dysphagia; mucositis; salivary dysfunction; xerostomia	At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Primary	Change in late toxicity	Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism	At 6,12,18,24,36,48,60 months after last day of completion of treatment
Primary	Change in patient-rated symptoms	Assessed by questionnaires	At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Primary	Change in patient-rated Quality-of-Life	Assessed by questionnaires	At 6,12,18,24,36,48,60 months after last day of completion of treatment