NCT06638216

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2024-10-15
• Last updated: 2025-08-28

Locations

1 site across 1 country: Germany