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

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 Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: A.P.G. Crijns, Dr.; Phone Number: +31503610039; Email: a.p.g.crijns@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: A.P.G. Crijns, Dr.; Phone Number: +31503610039; Email: a.p.g.crijns@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients ≥18 years still alive and treated since April 2007 for HNC at the department of Radiation Oncology of the UMCG, Groningen, the Netherlands

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in late toxicity	Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism	At 6,12,18,24,36,48,60 months after last day of completion of treatment
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
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimated): July 2, 2015

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Toxicity; Genome-wide association study; Polymorphism, single nucleotide; Head and Neck neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: RT2011-03