Physical Functioning Throughout Lung Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 6MWT
研究概览
简要总结
This trial investigates the impact of lung cancer treatment on physical status, symptoms and quality of life. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.
详细描述
Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 150 patients with lung cancer who are undergoing treatment. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy and/or immunotherapy). The aims of the study are to
- Investigate physical status, before start of treatment in lung cancer patients in comparison with healthy controls (primary outcome).
- Investigate changes in physical status over the course of treatment in lung cancer patients (primary outcome).
- Investigate the relationship between changes in physical status with physical activity and symptoms during treatment for lung cancer (secondary outcome).
- Investigate the relationship between physical status after treatment for lung cancer and comorbidities, hospitalizations and cancer-related and all-cause mortality (exploratory outcome).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones)
- •WHO performance status of maximal 2
排除标准
- •presence of other neoplasms in the last 2 years
- •bone metastasis
- •progressive neuromuscular and neurological diseases
- •unstable cardiac disease
- •pulmonary hypertension
- •interstitial lung disease
- •orthopedic conditions that significantly impair functional status
- •mental or psychiatric disorders that impair the ability to comply with study procedures.
- •a history of cerebrovascular accident with remaining functional consequences
- •a history of lung cancer
- •difficulties in understanding and speaking Dutch
结局指标
主要结局
6MWT
时间窗: Before start of treatment versus 3 months after treatment initiation
1-minute sit to stand test
时间窗: Before start of treatment versus 3 months after treatment initiation
SPPB
时间窗: Before start of treatment versus 3 months after treatment initiation
次要结局
- Quadriceps strength (isometric and isokinetic)(Before start of treatment vs. 3 months after treatment initiation)
- Daily physical activity (self-reported and accelerometer)(Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months after treatment initiation)
- Handgrip strength(Before start of treatment vs. 3 months after treatment initiation)
- Respiratory muscle strength (maximal inspiratory and expiratory pressure)(Before start of treatment vs. 3 months after treatment initiation)
研究者
Chris Burtin
Dr
Hasselt University