Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Feasibility, compliance
研究概览
简要总结
A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group
详细描述
In a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil.
The target of the dietary counselling is:
- 30 kcal/kg/d (in patients with BMI <30) or 25 kcal/kg/d (in patients with BMI => 30)
- at least 1.0 g protein/kg/d
- three daily meals of at least 20 g of protein
- restrict overnight fasting to a maximum of 11 hours
The initial dietary counselling is at the first cycle of anti-neoplastic treatment. The patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. At every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. At every week the patients will be prompted by telephone to comply with the dietary plan.
The physical exercise consists of two exercises:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Non-randomised
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
- •histopathologically or cytologically verified with NSCLC
- •inoperable tumour, candidates for, but naïve to or no systemic anti-neoplastic treatment the previous two years
- •commence first line of chemotherapy (carboplatin/vinorelbin, cisplatin/vinorelbin) with or without radiation therapy or pembrolizumab
- •performance status ≤2 (Eastern Cooperative Oncology Group)
- •age >18 and provided oral
- •written consent
排除标准
- •excessive alcohol or drug abuse
- •incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.
结局指标
主要结局
Feasibility, compliance
时间窗: 9-18 weeks
The overall compliance was defined successful if at least half of the included patients reached at least 75 % of the nutrient target, consumed at least 75 % of the fish oil and conducted at least 50 % of the physical exercises
Feasibility, retention rate
时间窗: 9 months
Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented
Feasibility, recruitment rate
时间窗: 9 months
Recruitment rate is measured by dividing the number of patients consented by the number of patients screened
次要结局
- Proportion of patients gaining, maintaining and wasting of skeletal muscle(9-18 weeks)
- Group difference in skeletal muscle(9-18 weeks)
- Change in physical function(9-18 weeks)
- Predictive and prognostic factors of change in skeletal muscle(9-18 weeks)
- Group difference in body weight(9-18 weeks)
研究者
Randi Tobberup
Ph.D. student
Aalborg University Hospital