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

NCT ID: NCT06638216

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2025-06-12

Brief 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.

Conditions

Head and Neck Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Geriatric Assessment

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.

Group Type: EXPERIMENTAL

Geriatric Assessment

Intervention Type: OTHER

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.

Interventions

Geriatric Assessment

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Franziska Hausmann

Assistant Professor for Experimental Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité University Medicine Berlin

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

EA1/168/24

Identifier Type: -

Identifier Source: org_study_id