Metastatic Pancreatic Cancer, Unresectable Locally Advanced Cancer
Conditions
Keywords
Unresectable, Pancreatic cancer, GERCOR, Adapted physical activity (APA), Quality of life, Fatigue
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.
Interventions
OTHERwithout APA program
Control Arm : chemotherapy alone
OTHERAPA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Short form questionnaire | Up to 24 months | — |
| Patient depression scale - HADS 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 |
| Number of Adverse events (AE) grade 3 -4 | up to 24 months | — |
| Progression free survival (PFS) | 2 years | — |
| Overall Survival (OS) | 2 years | — |
| Time To deterioration (TTD) | Up to 24 months | — |
| General state - Performance status OMS | up to 24 months | — |
| Fatigue scale (EVA fatigue) | up to 24 months | — |
| MFI-20 and EORTC QLQ C-30 evaluation | at 6, 12 et 24 months | — |
| medico-economic evaluation | up to 24 months | — |
| visual analog scale for pain | up to 24 months | — |
| analgesic consumption | up to 24 months | — |
| anxiolytic / antidepressant consumption | up to 24 months | — |
| Accompanying partner depression scale (HADS questionnaire) | up to 24 months | — |
Countries
France
Outcome results
None listed