Clinical trial · Interventional
Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy
NCT06638216CI-TRIAL-00094198PRE-KOVERIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed. Primary objective: Fragility is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geriatric Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Geriatric Assessment
- description
- Frailty is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
- interventionNames
- Other: Geriatric Assessment
Primary outcomes (1)
- measure
- Frailty
- timeFrame
- once prior to surgery or at beginning of radiation
- description
- Assessment via G8 (Geriatric Screening Tool) questionnaire consists of 8 questions. The score ranges from 0 (poor score) to 17 points (good score), and a score of 11 or lower indicated frailty, whereas a score between 12 and 14 equals pre-frail patients. Patients with a score above 14 are considert non-frail.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for curative therapy in the case of an initial diagnosis of head and neck tumor disease * Capacity to consent * At least 18 years of age * Sufficient knowledge of the German language Exclusion Criteria: * \- Lack of capacity to consent * Age \<18 years * Severe impairment of walking ability that makes it impossible to perform the 6MWT safely Contraindications for performing a 6MWT: Absolute contraindications\* for the procedure are * unstable angina pectoris * myocardial infarction in the past month. Relative contraindications are * a resting heart rate \> 120/min * systolic blood pressure \> 180 mmHg * a diastolic blood pressure \> 100 mmHg.
References
Publications (0)
Data not yet available
No reference posted for this study.