Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancers
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Frailty
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Prof. Dr. Franziska Hausmann
Assistant Professor for Experimental Radiation Oncology
Charite University, Berlin, Germany
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
Outcomes
Primary Outcomes
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
- EORTC-QLQ C30 questionnaire(prior to surgery or at beginning of radiotherapy)
- swallowing function(prior to surgery or beginning of radiation)
- Cardio-pulmonary resilience(prior to surgery or beginning of radiation)
- Epidemiologic Data(prior to surgery or beginning of radiation)
- Information on current tumor disease(prior to surgery or beginning of radiation)
- EORTC-H&N43 questionnaire(prior to surgery or at beginning of radiotherapy)