Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy in Patients With Various Tumor Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Protein uptake in g/kg body weight
研究概览
简要总结
The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. Therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. The aim is to determine the amount of energy and protein intake as well as the timing of protein intake. Furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.
详细描述
Many studies have shown that cancer patients have a very high prevalence of malnutrition. Several large-scale studies have reported that 50-80% of these patients are affected by involuntary weight loss, with the extent of weight loss depending on the tumor location and the type and stage of the disease. It has been widely reported that nutritional interventions are essential in cancer patients. Nevertheless, nutritional support is still not universally accessible to all patients. Given the prevalence of nutritional risks, the treatment of lean muscle mass loss remains a challenge in clinical practice. For this reason, a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology. A protein level of 1-1.2 g/kg bw is suggested for the maintenance of muscle mass.However, it has been shown that this amount is not sufficient to support ALM in patients with tumor diseases. Only an amount above 1.4 g/kg bw has been associated with a positive effect on muscle mass. Adequate dietary protein intake is essential for the maintenance of numerous physiological processes, including muscle protein synthesis and muscle function. Sufficient energy and protein intake is necessary to support muscle protein synthesis. The scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals. The evening meal is particularly important for the maintenance of ALM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity to consent
- •At least 45 years of age
- •Sufficient knowledge of the German language
- •Indication to undergo radio(chemo)therapy with at least 10 fractions
排除标准
- •Participation in other interventional studies
- •Pregnancy/breastfeeding
- •Previous intake of high-calorie supplementary food or intravenous nutrition
- •BMI < 18.5
- •When performing the bioimpedance measurement: patients with pacemakers, defibrillators and other implanted automatic devices
结局指标
主要结局
Protein uptake in g/kg body weight
时间窗: baseline, end of radiotherapy and 3 months after Radiotherapy
Change in the amount of protein consumed and its distribution over the main meals by means of a dietary questionnaire before, at the end and 3 months after completion of radiotherapy.
次要结局
- BMI in kg/m²(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Height in m(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Fatigue in 5-tier likert scale (higher scores = worse)(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse)(baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months))
- Weight in kg(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Muscle mass in kg(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better)(baseline, end of radiotherapy and 3 months after Radiotherapy)
- Treatment Toxicity via PROMs (5 tier scale; higher = worse)(baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months))
研究者
Prof. Dr. Franziska Hausmann
Principal Investigator
Charite University, Berlin, Germany