Pancreas Cancer, Quality of Life
Conditions
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).
Interventions
OTHERUnsupervised APA program
Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions.
OTHERSupervised APA program
Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions; in addition, patients will attend weekly supervised, hospital-based exercise sessions in groups of patients.
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M6 Health-Related quality of life (HRQoL) | 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. |
Countries
France
Contacts
Primary ContactNelly Roldan
Backup ContactChristine Delpeut
Outcome results
None listed