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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
313
Control Arm : chemotherapy alone
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
CHU Morvan
Brest, France
Hôpital Beaujon
Clichy, France
Health-related quality of life (HRQoL) at 16 weeks
HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.
Time frame: At 16 weeks
Time To deterioration (TTD)
Time frame: Up to 24 months
Brief Pain Inventory Short form questionnaire
Time frame: Up to 24 months
Patient depression scale - HADS questionnaire
Time frame: Up to 24 months
Nutritional status evaluation
Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)
Time frame: up to 24 months
Physical Activity evaluation - IPAQ questionnaire
Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program
Time frame: up to 24 months
Number of Adverse events (AE) grade 3 -4
Time frame: up to 24 months
Progression free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Accompanying partner depression scale (HADS questionnaire)
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Hôpital Henri Mondor
Créteil, 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
...and 7 more locations
Time frame: up to 24 months
General state - Performance status OMS
Time frame: up to 24 months
Fatigue scale (EVA fatigue)
Time frame: up to 24 months
MFI-20 and EORTC QLQ C-30 evaluation
Time frame: at 6, 12 et 24 months
medico-economic evaluation
Time frame: up to 24 months
visual analog scale for pain
Time frame: up to 24 months
analgesic consumption
Time frame: up to 24 months
anxiolytic / antidepressant consumption
Time frame: up to 24 months