Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 252
- Locations
- 15
- Primary Endpoint
- M6 Health-Related quality of life (HRQoL)
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Unsupervised APA program
usual care plus a 6-month unsupervised APA program
Intervention: Unsupervised APA program (Other)
Usual care
Usual care
Supervised APA program
usual care plus a 6-month supervised APA program
Intervention: Supervised APA program (Other)
Outcomes
Primary Outcomes
M6 Health-Related quality of life (HRQoL)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported