Clinical trial NCT03400072: Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Official title: Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Quality of Life
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: GERCOR - Multidisciplinary Oncology Cooperative Group
First posted: 2018-01-17
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: M6 Health-Related quality of life (HRQoL)
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Brest
country: France
facility: CHU de Brest
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital privé Jean Mermoz
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Cloud
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Henri Mondor University Hospital
name: Cindy Neuzillet, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Beaujon
name: Pascal Hammel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: