Physical activity in patients with unresectable pancreatic adenocarcinoma: A multicentric randomized controlled study (APACaP study).

Abstract

TPS506 Background: Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (QoL). It has been shown feasible and efficient in various cancers, including at advanced stage. Effects of physical activity in advanced pancreatic ductal adenocarcinoma (PDAC) have never been explored to date. We aim to evaluate the effects of a physical activity intervention in this setting. Methods: Randomized national multicentric interventional study to test the efficacy of an unsupervised home-based 16-week physical exercise program. Specificities of PDAC for physical activity program implementation will be taken into account (physical activity partner instead of patients groups, nutritional management). Main inclusion criteria: histologically confirmed, unresectable PDAC; scheduled for CT; WHO PS 0-2; age ≥ 18; physical activity partner. Two study arms: intervention group invited for the exercise program (aerobic and resistance exercises) in addition to usual care; control group receiving usual care alone. Primary objective: effects on fatigue (MFI-20) and health-related QoL (EORTC-QLQ-C30) at week 16, unified as co-primary endpoint. Secondary objectives: effects on pain, anxiety and depression, nutritional status, insulin resistance, CT tolerance, survival; adherence to the program. Number of patients: 200. PDAC patients are strongly affected by fatigue, thus they are expected to benefit from a physical activity intervention. Moreover, exercise may have a beneficial effect on tumor outcomes, by reducing insulin resistance and insulin/IGF-1 secretions. Such intervention may appear challenging because of multiple cancer-related symptoms (fatigue, depression, pain, denutrition) that can appear as barriers to physical activity. Conversely, we hypothesize that a physical exercise program, by taking into account PDAC specificities, may improve symptoms and health-related QoL. If this intervention is proven to be feasible and effective, such standardized physical exercise programs might be proposed in complement to CT in patients with advanced PDAC as a logical next step. Clinical trial information: NCT02184663.