Skip to main content
OpenTrials
Completed

NCT Number: NCT06638216

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Geriatric Assessment

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.

Primary outcomes

  1. Frailty

    Time frame: once prior to surgery or at beginning of radiation

    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.

Secondary outcomes

  1. EORTC-QLQ C30 questionnaire

    Time frame: prior to surgery or at beginning of radiotherapy

    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.

  2. swallowing function

    Time frame: prior to surgery or beginning of radiation

    Questionnaire (M.D. Anderson Dysphagia Inventory), scores range from 20 (poor function) to 100 (high function)

  3. Cardio-pulmonary resilience

    Time frame: prior to surgery or beginning of radiation

    6-Minute Walk test

  4. Epidemiologic Data

    Time frame: prior to surgery or beginning of radiation

    Descriptive (e.g. income, alcohol use, smoking status), epidemiologic data is not scored

  5. Information on current tumor disease

    Time frame: prior to surgery or beginning of radiation

    number of patients with T1/T2/T3/T4 Tumor Stage and N1/N2/N3 lymphonodal stage

  6. EORTC-H&N43 questionnaire

    Time frame: prior to surgery or at beginning of radiotherapy

    EORTC-H&N43 questionnaires. Scores are from 0 to 100. A high score indicates high level of symptamotology.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: PRE-KOVERI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.