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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pancreas Cancer, Quality of Life

Intervention / Treatment
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* Other: Unsupervised APA program
* Other: Supervised APA program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unsupervised APA program<br>usual care plus a 6-month unsupervised APA program | Other: Unsupervised APA program<br>* 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.<br>|
| Experimental: Supervised APA program<br>usual care plus a 6-month supervised APA program | Other: Supervised APA program<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M6 Health-Related quality of life (HRQoL) | 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. | month 6 |