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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02184663
• Other study ID #: APACaP D13-1
• Secondary ID: 2014-A00228-39
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2014
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 313
• Est. completion date: December 30, 2023
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms
• Unresectable Locally Advanced Cancer

Intervention

Other:
• without APA program
Control Arm : chemotherapy alone
• APA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

Locations

Country	Name	City	State
France	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	CH Mont de Marsan	Mont de Marsan
France	Centre Hospitalier de Belfort	Montbéliard
France	Hôpital Cochin	Paris
France	Hôpital Saint Antoine	Paris
France	CHU Robert Debré	Reims
France	Hôpital FOCH	Suresnes
France	Institut de cancérologie de Lorraine	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time To deterioration (TTD)		Up to 24 months
Secondary	Brief Pain Inventory Short form questionnaire		Up to 24 months
Secondary	Patient depression scale - HADS questionnaire		Up to 24 months
Secondary	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
Secondary	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
Secondary	Number of Adverse events (AE) grade 3 -4		up to 24 months
Secondary	Progression free survival (PFS)		2 years
Secondary	Overall Survival (OS)		2 years
Secondary	Accompanying partner depression scale (HADS questionnaire)		up to 24 months
Secondary	General state - Performance status OMS		up to 24 months
Secondary	Fatigue scale (EVA fatigue)		up to 24 months
Secondary	MFI-20 and EORTC QLQ C-30 evaluation		at 6, 12 et 24 months
Secondary	medico-economic evaluation		up to 24 months
Secondary	visual analog scale for pain		up to 24 months
Secondary	analgesic consumption		up to 24 months
Secondary	anxiolytic / antidepressant consumption		up to 24 months