Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy (PRE-KOVERI)

Charité University Medicine Berlin

Status: Completed

Conditions: Head and Neck Cancers

Treatments: Other: Geriatric Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06638216

EA1/168/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Geriatric Assessment

Experimental group

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.

Treatment:

Other: Geriatric Assessment