Prediction of Radiation-induced Swallowing Dysfunction after Curative (Chemo)Radiation for Head and Neck Cancer

Prediction of Radiation-induced Swallowing Dysfunction after Curative (Chemo)Radiation for Head and Neck Cancer - SLIK study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31538

Enrollment

240

Registered

2008-11-24

Start date

2008-06-02

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysphagia swallowing complaints

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - primary head and neck cancer (or lymph node metastases from an unknown primary) - stage I-IV (UICC staging system 2002) - no distant metastases - no postoperative radiotherapy / chemo-radiotherapy - previously untreated

Exclusion criteria

Exclusion criteria: - distant metastases - surgery

Design outcomes

Primary

Measure	Time frame
Grade 2 or more swallowing dysfunction at 6 months after completion of (chemo)radiation (according to the RTOG/EORTC system).	—

Secondary

Measure	Time frame
• Findings of videofluoroscopy. • Dysphagia, Esophageal Morbidity and Aspiration according to the Common Terminology Criteria for Adverse Events version 3.0. • Thickening of the pharyngeal constrictor muscles, the pharyngeal and laryngeal mucosa on CT-scan • Health related quality of life (EORTC QLQ-C30 and EORTC QLQ-H&N35) • Patient-rated swallowing complaints (SWAL-QoL)	—

Countries

Netherlands

Outcome results