Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Study Overview
=================
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.

Official Title
-----------------
Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Conditions
-----------------
Unresectable Locally Advanced Cancer, Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: without APA program
* Other: APA program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care without APA program<br>The control arm corresponds to usual care (without APA), including : Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol) Evaluation by the oncologist at the usual rate Assessment every 8 weeks (TAP scan + CA-19.9) Nutritional, psychological and pain management as recommended, according to the usual schedule. | Other: without APA program<br>* Control Arm : chemotherapy alone<br>|
| Experimental: Standard care with APA program<br>The experimental arm corresponds to usual care, combined with a 16-week APA program. The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner). | Other: APA program<br>* Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To deterioration (TTD) |  | Up to 24 months | 
| Brief Pain Inventory Short form questionnaire |  | Up to 24 months | 
| Patient depression scale - HADS questionnaire |  | 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) | 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 | up to 24 months | 
| Number of Adverse events (AE) grade 3 -4 |  | up to 24 months | 
| Progression free survival (PFS) |  | 2 years | 
| Overall Survival (OS) |  | 2 years | 
| Accompanying partner depression scale (HADS questionnaire) |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERCOR, Unresectable, Pancreatic cancer, Adapted physical activity (APA), Quality of life, Fatigue