Exercise-Based Pre-, Peri- and Post-Surgery Intervention to Improve Clinical and Translational Outcomes in Patients Undergoing Whipple's Procedure: A Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of the ExO-PanC exercise programme
研究概览
简要总结
Pancreatic cancer surgery (Whipple's procedure) is a major operation that can lead to reduced physical fitness, delayed recovery, and difficulty starting chemotherapy after surgery. Exercise before and after surgery may help improve recovery, but it is not known whether a personalised exercise programme delivered throughout the surgical pathway is practical or acceptable for patients.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study is a single-arm feasibility study that will recruit adults with suspected pancreatic ductal adenocarcinoma who are scheduled to undergo Whipple's procedure. Participants will receive an individualised exercise programme before surgery, during their hospital stay, and after discharge until the start of adjuvant chemotherapy. The programme will include aerobic exercise and resistance training prescribed according to each participant's fitness level.
The primary objective is to determine whether this exercise programme is feasible by assessing recruitment, participant adherence, compliance with the prescribed exercise programme, and retention. Secondary exploratory objectives include evaluating surgical complications, initiation of adjuvant chemotherapy, physical fitness, quality of life, nutritional status, and blood, stool, and tumour biomarkers associated with clinical outcomes. Findings from this feasibility study will inform the design of a future multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC programme.
详细描述
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor survival, reduced physical function, and a high burden of treatment-related morbidity. Patients undergoing pancreaticoduodenectomy (Whipple's procedure) often experience substantial declines in cardiorespiratory fitness and muscle function before and after surgery, which may contribute to postoperative complications, delayed recovery, and reduced likelihood of receiving adjuvant chemotherapy. While prehabilitation programmes are increasingly incorporated into routine care, current approaches are not typically individualised using objective measures of physical fitness and generally do not extend across the entire perioperative pathway.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study has been developed to evaluate the feasibility of a personalised exercise programme delivered before surgery, during hospital admission, and throughout postoperative recovery until the commencement of adjuvant chemotherapy. Exercise prescriptions will be individualised using cardiopulmonary exercise testing (CPET), muscle strength assessments, and functional performance measures, allowing exercise intensity and progression to be tailored to each participant's physiological capacity.
Participants will undergo repeated assessments of cardiorespiratory fitness, physical function, muscle strength, nutritional status, quality of life, and biological sampling throughout the study. Blood, stool, and surgically resected tumour tissue will be collected to explore biomarkers associated with clinical outcomes and responses to exercise.
The primary objective of this feasibility study is to determine whether the ExO-PanC intervention can be successfully delivered across the perioperative pathway by evaluating participant recruitment, adherence, compliance with prescribed exercise, and study retention. Exploratory analyses will investigate surgical complications, initiation of adjuvant chemotherapy, changes in physical fitness and quality of life, and relationships between biological markers and clinical outcomes.
Results from this study will establish the feasibility of implementing a personalised perioperative exercise programme for patients undergoing pancreatic cancer surgery and will provide essential data to inform the design of a future adequately powered multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults aged 18 years or older.
- •Planned to undergo upfront pancreatoduodenectomy (Whipple's procedure) for a suspected malignant periampullary mass.
- •Able and willing to provide written informed consent.
排除标准
- •<18 years age
- •Cardiopulmonary exercise test (CPET) contraindications
- •Physical inability to perform CPET or undertake the program.
- •Lacking the capacity to consent
- •Unable to understand instructions in English
- •Not scheduled for surgery
- •A new diagnosis of Type 1 or Type 3c diabetes requiring management with insulin prescription will be excluded from the study.
结局指标
主要结局
Feasibility of the ExO-PanC exercise programme
时间窗: From enrolment until completion of the intervention (approximately 16-24 weeks)
Feasibility will be assessed using participant recruitment, adherence to the prescribed exercise programme (target \>85% of prescribed sessions completed), compliance with prescribed exercise intensity, duration and type (target \>80%), and participant retention (target \<20% withdrawal for non-clinical reasons). Feasibility will be evaluated separately across the preoperative, perioperative and postoperative phases of the intervention.
次要结局
- Postoperative surgical complications(Up to approximately 6 weeks following surgery.)
- Commencement and completion of adjuvant chemotherapy(From surgery until planned commencement and completion of adjuvant chemotherapy.)
- Cardiorespiratory fitness (CRF) measured by cardiopulmonary excercise testing (CPET)(Baseline through completion of the intervention (approximately 16-24 weeks))
- Muscle strength(Baseline through completion of the intervention (approximately 16-24 weeks).)
- Change in health-related quality of life measured using the EORTC QLQ-C30(Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).)
- Nutritional status(Baseline through completion of the intervention (approximately 16-24 weeks).)
- Change in pancreatic cancer-specific quality of life measured using the EORTC QLQ-PAN26(This will be measured at five timepoints from recruitment through to commencement of adjuvant chemotherapy)