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Brief Title: Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
Official Title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Study ID: NCT02184663
Brief Summary: Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer. Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population
Detailed Description: The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment. The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy. 200 randomized patients are required. The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA). Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
CHU Morvan, Brest, , France
Hôpital Beaujon, Clichy, , France
Hôpital Henri Mondor, Creteil, , France
Centre Georges François Leclerc, Dijon, , France
CHD Vendée, La Roche Sur Yon, , France
Institut Hospitalier Franco-Britannique, Levallois Perret, , France
Centre Léon Bérard, Lyon, , France
CH Saint Joseph Saint Luc, Lyon, , France
Hôpital Européen, Marseille, , France
CH Mont de Marsan, Mont de Marsan, , France
Centre Hospitalier de Belfort, Montbéliard, , France
Hôpital Cochin, Paris, , France
Hôpital Saint Antoine, Paris, , France
CHU Robert Debré, Reims, , France
Hôpital FOCH, Suresnes, , France
Institut de cancérologie de Lorraine, Vandoeuvre Les Nancy, , France
Name: Pascal Hammel, MD
Affiliation: Hôpital Beaujon
Role: PRINCIPAL_INVESTIGATOR