BACKGROUND: Exercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and @entity5 , including @entity5 . Effects of physical activity have never been explored in advanced @entity1124 ( @entity1124 ). We aim to evaluate the effects of an exercise intervention in this setting. METHODS: This randomized, national, multicenter, interventional study will examine the effectiveness of an unsupervised, home-based, 16-week adapted physical activity (APA) program. Specificities of advanced @entity1124 for the implementation of the APA program will be taken into account (healthy volunteer as physical activity partner instead of @entity1 groups, nutritional management). The main inclusion criteria are: @entity1 with histologically confirmed, unresectable @entity1124 ; scheduled for chemotherapy; performance status 0-2; age   >=    18; and physical activity partner. In total, 200 @entity1 will be randomized into either the APA program (aerobic and resistance exercises) in addition to usual care (including chemotherapy at the investigator's choice), or usual care. The primary objective will be the effect on fatigue (Multidimensional Fatigue Inventory, MFI-20) and HRQoL (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC-QLQ-C30; co-primary endpoint) at week 16. As secondary objectives, the effects of the exercise intervention on @entity158 , @entity148 , @entity308 , nutritional status, insulin resistance, tolerance of chemotherapy, survival, and adherence to the APA program will be evaluated. DISCUSSION: @entity1 with advanced @entity1124 are strongly affected by fatigue, and are thus likely to benefit from an exercise intervention. Moreover, exercise may have a potential beneficial effect on @entity5 outcome by reducing @entity442 ) secretion. However, an exercise intervention may appear challenging due to multiple @entity1124 -related symptoms such as fatigue, @entity308 , @entity158 , and denutrition. We hypothesize that an APA program taking into account specific characteristics of @entity1124 may improve symptoms and HRQoL. If demonstrated to be feasible and effective, such APA programs will be systematically proposed to @entity1 with advanced @entity1124 in addition to usual care. TRIAL REGISTRATION: ClinicalTrial.gov REGISTRATION NUMBER: NCT02184663 ; Registration date: 2 July 2014.

Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer XXXX (APACaP) GERCOR (Groupe Coop  rateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity308 :: ('MESH:D003866', 'Disease') :: ['depression'] @entity1124 :: ('MESH:D021441', 'Disease') :: ['PDAC', 'pancreatic ductal adenocarcinoma'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'advanced-stage cancers', 'efficient in various cancers'] @entity442 :: ('3479', 'Gene') :: ['insulin resistance and insulin/insulin-like growth factor-1 (IGF-1'] @entity148 :: ('MESH:D001008', 'Disease') :: ['anxiety'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain']
@entity1 :: (9606,Species) :: ['patients']
