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

Quality of Life Clinical Trial

— APACaPOp  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400072
• Other study ID #: P/2017/317
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: August 2024

Study information

• Verified date: November 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Nelly Roldan
• Phone: 00336 34 46 62 51
• Email: nelly.roldan[@]gercor.com.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: August 2024
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms
• Quality of Life

Intervention

Other:
• Unsupervised 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.
• Supervised 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.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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