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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancers
• Intervention / Treatment: Other: Geriatric Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • State of Berlin
    • Berlin, State of Berlin, Germany, 13353
      • Charité University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	Assessment via G8 (Geriatric Screening Tool) questionnaire consists of 8 questions. The score ranges from 0 (poor score) to 17 points (good score), and a score of 11 or lower indicated frailty, whereas a score between 12 and 14 equals pre-frail patients. Patients with a score above 14 are considert non-frail.	once prior to surgery or at beginning of radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC-QLQ C30 questionnaire	EORTC-QLQ C30 questionnaire consist of 30 questions with a score range from 0 to 100. Higher scores represents better quality of life, low scores indicating lower quality of life.	prior to surgery or at beginning of radiotherapy
swallowing function	Questionnaire (M.D. Anderson Dysphagia Inventory), scores range from 20 (poor function) to 100 (high function)	prior to surgery or beginning of radiation
Cardio-pulmonary resilience	6-Minute Walk test	prior to surgery or beginning of radiation
Epidemiologic Data	Descriptive (e.g. income, alcohol use, smoking status), epidemiologic data is not scored	prior to surgery or beginning of radiation
Information on current tumor disease	number of patients with T1/T2/T3/T4 Tumor Stage and N1/N2/N3 lymphonodal stage	prior to surgery or beginning of radiation
EORTC-H&N43 questionnaire	EORTC-H&N43 questionnaires. Scores are from 0 to 100. A high score indicates high level of symptamotology.	prior to surgery or at beginning of radiotherapy

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Frailty; Radiation; Geriatric Assessment; Maxillo-facial Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Pathological Conditions, Signs and Symptoms; Frailty; Head and Neck Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Population Characteristics; Health Status; Demography; Epidemiologic Measurements; Geriatric Assessment
• Other Study ID Numbers: EA1/168/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No