Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

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).

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.