Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
APACaPOp
1 other identifier
interventional
252
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedStudy Start
First participant enrolled
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedNovember 19, 2018
November 1, 2018
3.5 years
January 9, 2018
November 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Unsupervised APA program
EXPERIMENTALusual care plus a 6-month unsupervised APA program
Supervised APA program
EXPERIMENTALusual care plus a 6-month supervised APA program
Usual care
NO INTERVENTIONUsual care
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
CHU de Besançon
Besançon, 25000, France
CHU de Brest
Brest, France
Hôpital Beaujon
Clichy, France
Hôpital Henri Mondor
Créteil, France
Hôpital Edouard Herriot
Lyon, France
Hôpital privé Jean Mermoz
Lyon, France
CHR d'Orléans
Orléans, France
Hôpital Cochin
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Haut-Lévêque
Pessac, France
CHU de Reims
Reims, France
CHU de Rouen
Rouen, France
Institut Curie
Saint-Cloud, France
Centre Paul Strauss
Strasbourg, France
CHU de Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy Neuzillet, MD PhD
Henri Mondor University Hospital
- PRINCIPAL INVESTIGATOR
Pascal Hammel, MD PhD
Hôpital Beaujon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 17, 2018
Study Start
August 3, 2018
Primary Completion
February 1, 2022
Study Completion
August 1, 2024
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share