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

Not Applicable

• Conditions: Pancreas Cancer; Quality of Life
• Interventions: Other: Supervised APA program; Other: Unsupervised APA program

• Registration Number: NCT03400072
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-08-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19
• Primary Completion: 2022-02
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised APA program	Supervised APA program	usual care plus a 6-month supervised APA program
Unsupervised APA program	Unsupervised APA program	usual care plus a 6-month unsupervised APA program

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (15)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital privé Jean Mermoz; 🇫🇷 Lyon, France

CHU de Toulouse; 🇫🇷 Toulouse, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU de Brest; 🇫🇷 Brest, France

Hôpital Beaujon; 🇫🇷 Clichy, France

CHR d'Orléans; 🇫🇷 Orléans, France

CHU de Rouen; 🇫🇷 Rouen, France

Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

CHU de Reims; 🇫🇷 Reims, France

Hôpital Cochin; 🇫🇷 Paris, France

CHU de Besançon; 🇫🇷 Besançon, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Saint-Cloud, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France