Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Comprehensive Complication Index (CCI)
研究概览
简要总结
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes.
The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery.
In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored.
Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
详细描述
BACKGROUND:
Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal cancer, with 5-year survival around 10%. The combination of surgical resection and chemotherapy represents the most efficacious therapy to improve prognosis for localized PDAC. Patients with pancreatic cancer are generally older adults in whom frailty, sarcopenia and/or malnutrition are common. These features have all been associated with poor postoperative complications and reduced survival. Therefore, the preoperative period and the time window after the end of chemotherapy constitute a unique opportunity to condition modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserves, which might otherwise preclude surgery or significantly impede recovery.
Prehabilitation is defined as the process of enhancing patients' functional capacity to enable them to withstand a stressful event. Multimodal prehabilitation, which defines a program including physical, nutritional, and psychological interventions, has shown the most promising results in gastrointestinal cancer surgery. However, no high-quality evidence is currently available for PDAC patients.
STUDY OBJECTIVES:
Primary Aim: to evaluate if a 4-week multimodal structured prehabilitation program including physical exercise, nutritional and psychological interventions will result in a clinically significant increase in functional capacity, nutritional status and patient-reported health-related quality of life before surgery when compared to a usual care control group, and evaluate the extent to which multimodal prehabilitation impacts on postoperative morbidity and patient recovery compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trial is designed as a randomized, controlled, assessor-blind trial.
Patient and investigator blinding will not be feasible due to the nature of the intervention and the direct involvement of the prehabilitation team. However, to minimize potential blinding and performance biases, enrolled patients will be informed that we will compare two types of strategies (prehabilitation and usual care), both aiming at improving their health conditions and fitness before surgery, and neither will be presented as potentially superior.
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
- •Age ≥ 18 years
- •Indication for curative resection for pancreatic or periampullary cancer
- •Signed Informed consent
排除标准
- •Metastatic or unresectable disease found preoperatively
- •Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine >250 mmol)
- •ASA score 4-5
- •Pregnancy
- •Illiteracy (inability to read and understand Italian language)
结局指标
主要结局
Comprehensive Complication Index (CCI)
时间窗: 90 days after surgery
Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI). The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100.
Comprehensive Complication Index (CCI)
时间窗: 90 days after surgery
Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI). The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100.
次要结局
- Time to patient functional recovery (TFR)(90 days after surgery)
- Lenght of stay (LOS)(90 days after surgery)
- Functional capacity(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Nutritional status(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Bioimpedance analysis (BIA) derived body composition(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Computed tomography derived body composition(One day before surgery.)
- Patient reported anxiety and depression(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Cancer cachexia related factors(One day before surgery)
- Generic health-related quality of life(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Disease-specific health-related quality of life(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Patient engagement and activation(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Pro-inflammatory cytokines(One day before surgery)
- Patient reported anxiety and depression(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Disease-specific health-related quality of life(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Time to patient functional recovery (TFR)(90 days after surgery)
- Lenght of stay (LOS)(90 days after surgery)
- Functional capacity(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Nutritional status(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Bioimpedance analysis (BIA) derived body composition(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Computed tomography derived body composition(One day before surgery.)
- Generic health-related quality of life(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery)
- Patient engagement and activation(One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.)
- Pro-inflammatory cytokines(One day before surgery)
- Cancer cachexia related factors(One day before surgery)
研究者
Nicolò Pecorelli
Principal Investigator
IRCCS San Raffaele