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

Trial Title: Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy

NCT ID: NCT06638216

Condition: Head and Neck Cancers

Conditions: Official terms:
Head and Neck Neoplasms
Frailty

Conditions: Keywords:
Head and Neck Cancer
Frailty
Geriatric Assessment
Radiation
Maxillo-facial Surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: 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.
Arm group label: Geriatric Assessment

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.

Detailed description: In this prospective study patients with a tumor of the head and neck region, that are planned for Surgery or radiotherapy (chemotherapy) will be included. The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. In addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. Due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. In addition, we want to determine influencing factors that are associated with fragility. These include, for example, difficulty swallowing and weight loss. Based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Charité University Medicine Berlin

Address:
City: Berlin
Zip: 13353
Country: Germany

Status: Recruiting

Contact:
Last name: Franziska Hausmann

Phone: +49 30 450 527 152

Start date: October 7, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Charite University, Berlin, Germany
Agency class: Other

Source: Charite University, Berlin, Germany

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06638216