Clinical trial NCT02184663: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Unresectable Locally Advanced Cancer
Metastatic Pancreatic Cancer
Keywords: Unresectable
Pancreatic cancer
GERCOR
Adapted physical activity (APA)
Quality of life
Fatigue
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Health-related quality of life (HRQoL) at 16 weeks
timeFrame: At 16 weeks
Secondary outcomes:
measure: Time To deterioration (TTD)
timeFrame: Up to 24 months
measure: Brief Pain Inventory Short form questionnaire
timeFrame: Up to 24 months
measure: Patient depression scale - HADS questionnaire
timeFrame: Up to 24 months
measure: Nutritional status evaluation
timeFrame: up to 24 months
measure: Physical Activity evaluation - IPAQ questionnaire
timeFrame: up to 24 months
measure: Number of Adverse events (AE) grade 3 -4
timeFrame: up to 24 months
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Accompanying partner depression scale (HADS questionnaire)
timeFrame: up to 24 months
measure: General state - Performance status OMS
timeFrame: up to 24 months
measure: Fatigue scale (EVA fatigue)
timeFrame: up to 24 months
measure: MFI-20 and EORTC QLQ C-30 evaluation
timeFrame: at 6, 12 et 24 months
measure: medico-economic evaluation
timeFrame: up to 24 months
measure: visual analog scale for pain
timeFrame: up to 24 months
measure: analgesic consumption
timeFrame: up to 24 months
measure: anxiolytic / antidepressant consumption
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brest
country: France
facility: CHU Morvan
city: Clichy
country: France
facility: Hôpital Beaujon
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Levallois Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Marseille
country: France
facility: Hôpital Européen
city: Mont de Marsan
country: France
facility: CH Mont de Marsan
city: Montbéliard
country: France
facility: Centre Hospitalier de Belfort
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Reims
country: France
facility: CHU Robert Debré
city: Suresnes
country: France
facility: Hôpital FOCH
city: Vandoeuvre Les Nancy
country: France
facility: Institut de cancérologie de Lorraine
Study officials:
affiliation: Hôpital Beaujon
name: Pascal Hammel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.