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Post-radiogenic Xerostomia and its Impact on the Quality of Life in Patients with Head and Neck Tumors

Post-radiogenic Xerostomia and its Impact on the Quality of Life in Patients with Head and Neck Tumors - PRIX-HNT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036144
Enrollment
150
Registered
2025-02-10
Start date
2025-03-15
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

C00-C14 C32 K11.7 T22 T23 T24 T25 T26-T28 T29-T32 R68.2

Interventions

Group 1: Survey of patients in the self-help network Kopf-Hals-M.U.N.D.-Krebs e.V. and the Federal Association for Laryngeal and Head and Neck Tumors e.V.
additionally, inclusion of patients in the tumor consultation of the Department of Oral and Maxillofacial Surgery at the University Medical Center Göttingen.

Sponsors

Klinik für Mund-, Kiefer- und Gesichtschirurgie der Universitätsmedizin Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients with a confirmed diagnosis of head and neck tumors, including: Oral cavity carcinomas (C00-C06) Pharyngeal carcinomas (C09-C14) Laryngeal carcinomas (C32) Tumors of the nose, paranasal sinuses (C30-C31), tongue, and thyroid gland (C73) Completion of curative or palliative radiation therapy in the head and neck region Minimum age of 18 years at the time of study participation Ability to complete the questionnaire independently or with supportive assistance Written informed consent for study participation in accordance with the ethical guidelines of the University Medical Center Göttingen

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients with ongoing or planned radiation therapy Pre-existing xerostomia due to other primary causes (e.g., Sjögren’s syndrome, uncontrolled diabetes mellitus, medication-induced hyposalivation) Severe cognitive impairments or neurological disorders preventing adequate questionnaire completion Lack of capacity to provide informed consent Participation in other clinical studies that could introduce bias regarding xerostomia outcomes

Design outcomes

Primary

MeasureTime frame
Quality of Life in Post-Radiogenic Xerostomia Assessment of xerostomia severity and its impact on daily life using standardized questionnaires (e.g., Xerostomia Questionnaire, OHIP-14). Subjective patient evaluation of quality of life (restrictions in eating, sleeping, and social interactions). Comparison of results between patients from self-help groups and those from the tumor consultation clinic.

Secondary

MeasureTime frame
Factors Influencing Xerostomia Correlation between radiation dose and severity of xerostomia. Effects of adjunct therapies (e.g., saliva stimulants, physiotherapy) on symptom severity. Changes in dietary habits and fluid intake in response to xerostomia. Psychosocial Burden & Coping Strategies Comparison of coping mechanisms between self-help group members and non-organized patients. Prevalence of depression or anxiety disorders in relation to post-radiogenic xerostomia.

Countries

Germany

Contacts

Public ContactGeorg Hoene

Klinik für Mund-, Kiefer- und Gesichtschirurgie der Universitätsmedizin Göttingen

georg.hoene@med.uni-goettingen.de+495513963844

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026