Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Frailty
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
结局指标
主要结局
Frailty
时间窗: 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.
次要结局
- 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)
研究者
Prof. Dr. Franziska Hausmann
Assistant Professor for Experimental Radiation Oncology
Charite University, Berlin, Germany