Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
- Conditions
- Metastatic Pancreatic CancerUnresectable Locally Advanced Cancer
- Registration Number
- NCT02184663
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 313
- Histologically proven non resectable pancreatic adenocarcinoma
- Indication of palliative chemotherapy
- Life expectancy ≥ 3 months
- Eastern Cooperative oncology group (ECOG) - Performance status ≤2
- Age ≥18 years old
- At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
- Identified Accompanying partner Adapted Physical Activity (AAPA)
- Signed and dated informed consent
- Registration in a National Health Care System (CMU included for France)
- Previous Cerebrovascular accident or myocardial infarction <6months
- Uncontrolled hypertension.
- Severe cardiovascular or respiratory disease
- Severe cognitive or psychiatric disorder
- Severe motor and/or sensory neuropathy
- Rheumatologic or orthopedic problem or bone lesions with a fracture risk
- Others comorbidities contra-indicated physical exercises
- Patient protected by the law - Guardianship and trusteeship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Health-related quality of life (HRQoL) at 16 weeks 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.
- Secondary Outcome Measures
Name Time Method General state - Performance status OMS up to 24 months medico-economic evaluation up to 24 months Time To deterioration (TTD) Up to 24 months Brief Pain Inventory Short form questionnaire Up to 24 months Nutritional status evaluation up to 24 months 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)
Physical Activity evaluation - IPAQ questionnaire up to 24 months Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program
Progression free survival (PFS) 2 years Patient depression scale - HADS questionnaire Up to 24 months Accompanying partner depression scale (HADS questionnaire) up to 24 months Number of Adverse events (AE) grade 3 -4 up to 24 months analgesic consumption up to 24 months Overall Survival (OS) 2 years Fatigue scale (EVA fatigue) up to 24 months visual analog scale for pain up to 24 months MFI-20 and EORTC QLQ C-30 evaluation at 6, 12 et 24 months anxiolytic / antidepressant consumption up to 24 months
Trial Locations
- Locations (17)
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
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