CompletedNot Applicable

Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy

Germany99 participantsStarted 2024-10-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frailty

Timeframe: once prior to surgery or at beginning of radiation

Trial details

NCT IDNCT06638216

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-12

View on ClinicalTrials.gov More Head and Neck Cancers trials