Late Toxicity and long-term quality of life after radiotherapy for head and neck cancer

Late Toxicity and long-term quality of life after radiotherapy for head and neck cancer - CLEAR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037256

Enrollment

179

Registered

2025-07-07

Start date

2025-07-24

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

C00-C14 C32

Interventions

Group 1: One-time evaluation of head and neck specific quality of life using EORTC QLQ-C30, EORTC QLQ-H&N43 and MD Anderson Dysphagio Inventory and collection of data regarding sociodemographic status

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: RT for head and neck cancer between 2016 and 2019 (included)

Exclusion criteria

Exclusion criteria: Patients with dementia Patients with insufficient knowledge of German Patients who are unable to complete the questionnaires collected in the study independently

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the swallowing function measured with the EORTC QLQ-H&N43 as a function of the mean radiation dose to the constrictor pharyngeal muscle. The EORTC QLQ-H&N43 is assessed once during the study, the mean radiation dose is determined on the basis of the old radiation plans.	—

Secondary

Measure	Time frame
2.1 What are the predictors of increased long-term toxicity (= grade 2)? (Main focus: swallowing function) 2.2 How strongly is late toxicity associated with acute toxicity (measured 3 months after RT)? 2.3 Is the toxicity comparable to that of patients with the same initial oncological situation in other countries? 2.4 Is the quality of life comparable to that of patients with the same initial oncological situation in other countries?	—

Measure

Time frame

2.1 What are the predictors of increased long-term toxicity (= grade 2)? (Main focus: swallowing function) 2.2 How strongly is late toxicity associated with acute toxicity (measured 3 months after RT)? 2.3 Is the toxicity comparable to that of patients with the same initial oncological situation in other countries? 2.4 Is the quality of life comparable to that of patients with the same initial oncological situation in other countries?

—

Countries

Germany

Contacts

Public ContactJustus Kaufmann

Klinik und Poliklinik für Radioonkologie und Strahlentherapie der Universitätsmedizin Mainz

Justus.Kaufmann@unimedizin-mainz.de+49 6131 17 6155

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026