Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 试验地点
- 16
- 主要终点
- M6 Health-Related quality of life (HRQoL)
研究概览
简要总结
Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.
This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).
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
- 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
- •Histologically proven PDAC
- •Complete macroscopic resection (R0 or R1 resection)
- •Patients randomized within 12 weeks of surgery
- •No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs
- •Sufficient recovery from the operation and fit to take part in the trial
- •Able to attend for administration of the adjuvant CT
- •ECOG PS 0-2
- •Age ≥ 18 years
- •Life expectancy > 3 months
- •Dated and signed informed consent
- •Registration in a national health care system (CMU included).
排除标准
- •Macroscopically remaining tumor (R2 resection or TNM stage IV disease)
- •Histology other than PDAC
- •Cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological condition contra-indicating exercise practice
- •Pregnancy or breastfeeding
- •Protected adults (individuals under guardianship by court order). Note: participation to another concomitant clinical trial is allowed but the patient must inform and get an authorization from the Investigator.
研究组 & 干预措施
Unsupervised APA program
usual care plus a 6-month unsupervised APA program
干预措施: Unsupervised APA program (Other)
Supervised APA program
usual care plus a 6-month supervised APA program
干预措施: Supervised APA program (Other)
Usual care
Usual care
结局指标
主要结局
M6 Health-Related quality of life (HRQoL)
时间窗: month 6
HRQoL will be assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ) C30 at M6, with the following targeted dimensions: global QoL, fatigue, physical functioning, and pain.
次要结局
未报告次要终点