title: Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.
abstract: 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 efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). 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 PDAC for the implementation of the APA program will be taken into account (healthy volunteer as physical activity partner instead of patient groups, nutritional management). The main inclusion criteria are: patients with histologically confirmed, unresectable PDAC; scheduled for chemotherapy; performance status 0-2; age ≥ 18; and physical activity partner. In total, 200 patients 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 pain, anxiety, depression, nutritional status, insulin resistance, tolerance of chemotherapy, survival, and adherence to the APA program will be evaluated.
  
  
  CONCLUSIONS
  Patients with advanced PDAC are strongly affected by fatigue, and are thus likely to benefit from an exercise intervention. Moreover, exercise may have a potential beneficial effect on tumor outcome by reducing insulin resistance and insulin/insulin-like growth factor-1 (IGF-1) secretion. However, an exercise intervention may appear challenging due to multiple PDAC-related symptoms such as fatigue, depression, pain, and denutrition. We hypothesize that an APA program taking into account specific characteristics of PDAC may improve symptoms and HRQoL. If demonstrated to be feasible and effective, such APA programs will be systematically proposed to patients with advanced PDAC in addition to usual care.
  
  
  BACKGROUND
  ClinicalTrial.gov
  
  
  BACKGROUND
  NCT02184663 ; Registration date: 2 July 2014.
authors.affiliation: Digestive Oncology Department and UMR1149, Beaujon University Hospital, Hôpitaux Universitaires Paris Nord Val de Seine (HUPNVS), Assistance Publique-Hôpitaux de Paris (AP-HP), 92110, Clichy La Garenne, France. cindy.neuzillet@orange.fr.
authors.forename: Cindy
authors.initials: C
authors.lastname: Neuzillet
authors.affiliation: Visio Activités Sportives Interactives (V@si SARL), 34270, Saint Mathieu de Tréviers, France. mathieu.vergnault@vas-i.fr.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Vergnault
authors.affiliation: Methodology and Quality of Life in Oncology unit (EA 3181) and Quality of Life and Cancer Clinical Research Platform, Besançon University Hospital, 25000, Besançon, France. franck.bonnetain@univ-fcomte.fr.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Digestive Oncology Department and UMR1149, Beaujon University Hospital, Hôpitaux Universitaires Paris Nord Val de Seine (HUPNVS), Assistance Publique-Hôpitaux de Paris (AP-HP), 92110, Clichy La Garenne, France. pascal.hammel@bjn.aphp.fr.
authors.forename: Pascal
authors.initials: P
authors.lastname: Hammel
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D021441:Carcinoma, Pancreatic Ductal / Q000175:diagnosis / Q000628:therapy*; D002985:Clinical Protocols; D005602:France; D006304:Health Status; D006801:Humans; D010190:Pancreatic Neoplasms / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D055070:Resistance Training / Q000009:adverse effects; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents