Status:
UNKNOWN
Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Pancreas Cancer
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT03400072
Start Date
August 3 2018
End Date
August 1 2024
Last Update
November 19 2018
Active Locations (15)
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1
CHU de Besançon
Besançon, France, 25000
2
CHU de Brest
Brest, France
3
Hôpital Beaujon
Clichy, France
4
Hôpital Henri Mondor
Créteil, France