Charité University Medicine Berlin
Berlin, State of Berlin, 13353, Germany
NCT Number: NCT06638216
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Berlin, State of Berlin, 13353, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contraindications for performing a 6MWT:
Absolute contraindications* for the procedure are
Relative contraindications are
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.
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.
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.
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)
Time frame: prior to surgery or beginning of radiation
6-Minute Walk test
Time frame: prior to surgery or beginning of radiation
Descriptive (e.g. income, alcohol use, smoking status), epidemiologic data is not scored
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
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.
Charite University, Berlin, Germany
Other
Acronym: PRE-KOVERI
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