The Effect of Neoadjuvant Chemotherapy on Exercise Capacity and Outcome Following Upper Gastrointestinal Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- The relative decrease in exercise capacity (LT) associated with NAC prior to upper gastrointestinal cancer resection will predict outcome (1 year mortality) following surgery.
研究概览
简要总结
Neoadjuvant chemotherapy (NAC) prior to surgery for upper gastrointestinal (oesophageal and gastric) cancer is associated with improved survival. The investigators propose a prospective blinded observational cohort study of patients undergoing NAC prior to elective upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS teaching hospitals. The investigators have pilot data showing that NAC reduces objectively measured exercise capacity (fitness). The literature suggests that a lower level of exercise capacity is associated with a high risk of adverse outcome (death and serious complications) after major surgery.
The investigators wish to explore the hypothesis that decrease in exercise capacity (fitness) associated with (NAC) prior to upper gastrointestinal cancer resection may outweigh the benefits (duration of survival) achieved by NAC in some patients undergoing upper gastrointestinal cancer surgery. The investigators aim to recruit 175 patients from over 36 months. Consenting patients will perform cardiopulmonary exercise testing (CPET) and complete a quality of life questionnaire prior to and 4 weeks after NAC . Postoperative outcomes measured at set time points will be objective recorded including mortality 1 year after surgery and short term postoperative harm described by the PostOperative Morbidity Survey (POMS) as well as Quality of life scores and resource use (e.g. hospital bed utilisation). Exercise capacity (fitness) before and after NAC will be assessed using CPET and the relationship between the derived variables (AT, VO2 peak) and clinical outcomes will be described.
详细描述
STUDY SUMMARY
The investigators propose a prospective blinded observational cohort study of patients undergoing NAC prior to elective upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS teaching hospitals. Exercise capacity (fitness) before and after NAC will be assessed using CPET and the relationship between the derived variables (AT, VO2 peak) and clinical outcomes will be described. Postoperative outcomes will be objective recorded clinically meaningful and will include mortality 1 year after surgery and short term postoperative harm described by the PostOperative Morbidity Survey (POMS) Quality of lifer using the EQ5D questionnaire and resource use (e.g. hospital bed utilization). The hypotheses will be tested by constructing predictive models incorporating exercise variables and factors known to be related to outcome following surgery (e.g. age, gender, open versus laparoscopic surgery). For example, for the Primary Hypothesis, models will be developed to predict the risk of one year mortality using (i) baseline exercise capacity and (ii) baseline exercise capacity and the relative decrease in exercise capacity. The aim will be to compare the predictive ability of both models to ascertain how prognostic the relative decrease in exercise capacity is, after adjusting for baseline exercise. In addition, Hypothesis 1 will be investigated by comparing AT before and after NAC using a paired t-test and Hypothesis 2 will be investigated by comparing the risk of 1year mortality between patients who stay in the same AT band and those who deteriorate using a chi squared test. Logistic regression will be used to repeat the analysis adjusting for potential confounders.
Study Conduct
This study will be undertaken within Southampton University Hospitals NHS Trust, Aintree University Hospitals NHS Foundation Trust, and University Hospitals, Bristol. All research staff will have evidence of up to date GCP training and investigators with direct patient contact will undergo a formal consenting course.
STUDY PROCESS
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •all patients listed to undergo elective upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) and NAC in the three NHS teaching hospitals (Bristol Royal infirmary, Aintree University Hospitals NHS Foundation Trust (and Liverpool University Hospitals), Southampton General Hospital).
排除标准
- •Unable to consent. Under 18 years of age
结局指标
主要结局
The relative decrease in exercise capacity (LT) associated with NAC prior to upper gastrointestinal cancer resection will predict outcome (1 year mortality) following surgery.
时间窗: three years
次要结局
- Patients whose LT changes following NAC so that they move into a higher risk category will have a worse outcome (1 year mortality) when compared with those who do not increase risk category.(3 years)
研究者
Michelle Mossa
Director of Research and Development
Liverpool University Hospitals NHS Foundation Trust