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

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Quality of Life; Pancreas Cancer

Treatments: Other: Unsupervised APA program; Other: Supervised APA program

Study type: Interventional

Funder types: Other

Identifiers

NCT03400072

P/2017/317

Details and patient eligibility

About

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).

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 3 patient groups

Unsupervised APA program

Experimental group

Description:

usual care plus a 6-month unsupervised APA program

Treatment:

Other: Unsupervised APA program

Supervised APA program

Experimental group

Description:

usual care plus a 6-month supervised APA program

Treatment:

Other: Supervised APA program

Usual care

No Intervention group

Description:

Usual care