Evaluating frailty in patients with head and neck tumors before treatment
Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy
NA · Charite University, Berlin, Germany · NCT06638216
This study tests how fragile patients with head and neck tumors are before starting treatment to see if it affects their side effects and quality of life, helping to create a better support program for them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06638216 on ClinicalTrials.gov |
What this trial studies
This study assesses the fragility of patients diagnosed with head and neck tumors prior to initiating curative therapy. Using the G8 questionnaire, the study aims to identify patients at risk of therapy-related side effects due to their pre-existing conditions. Additionally, it evaluates quality of life, swallowing function, and cardiopulmonary resilience through various assessments. The findings will inform the development of a prehabilitation program tailored for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are diagnosed with head and neck tumors and are eligible for curative therapy.
Not a fit: Patients under 18 years old or those with severe walking impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and quality of life for patients with head and neck cancers.
How similar studies have performed: Other studies have shown success in assessing frailty in cancer patients, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Berlin
- Charité University Medicine Berlin — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Franziska Hausmann, Prof. Dr.
- Email: franziska.hausmann@charite.de
- Phone: +49 30 450 527 152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancers, Head and Neck Cancer, Frailty, Geriatric Assessment, Radiation, Maxillo-facial Surgery