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

September 26, 2023 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Brest, France
        • CHU Morvan
      • Clichy, France
        • Hopital Beaujon
      • Creteil, France
        • Hopital Henri Mondor
      • Dijon, France
        • Centre Georges François Leclerc
      • La Roche Sur Yon, France
        • CHD Vendée
      • Levallois Perret, France
        • Institut hospitalier franco-britannique
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • CH Saint Joseph Saint Luc
      • Marseille, France
        • Hopital Europeen
      • Mont de Marsan, France
        • CH Mont de Marsan
      • Montbéliard, France
        • Centre Hospitalier de Belfort
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hopital Cochin
      • Reims, France
        • CHU Robert Debré
      • Suresnes, France
        • Hopital Foch
      • Vandoeuvre Les Nancy, France
        • Institut de Cancerologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care without APA program

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
Control Arm : chemotherapy alone
Experimental: Standard care with APA program

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
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQoL) at 16 weeks
Time Frame: 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
Overall Survival (OS)
Time Frame: 2 years
2 years
Progression free survival (PFS)
Time Frame: 2 years
2 years
Time To deterioration (TTD)
Time Frame: Up to 24 months
Up to 24 months
Brief Pain Inventory Short form questionnaire
Time Frame: Up to 24 months
Up to 24 months
Patient depression scale - HADS questionnaire
Time Frame: Up to 24 months
Up to 24 months
Nutritional status evaluation
Time Frame: 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)
up to 24 months
Physical Activity evaluation - IPAQ questionnaire
Time Frame: up to 24 months
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
Time Frame: up to 24 months
up to 24 months
Accompanying partner depression scale (HADS questionnaire)
Time Frame: up to 24 months
up to 24 months
General state - Performance status OMS
Time Frame: up to 24 months
up to 24 months
Fatigue scale (EVA fatigue)
Time Frame: up to 24 months
up to 24 months
MFI-20 and EORTC QLQ C-30 evaluation
Time Frame: at 6, 12 et 24 months
at 6, 12 et 24 months
medico-economic evaluation
Time Frame: up to 24 months
up to 24 months
visual analog scale for pain
Time Frame: up to 24 months
up to 24 months
analgesic consumption
Time Frame: up to 24 months
up to 24 months
anxiolytic / antidepressant consumption
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Principal Investigator: Pascal HAMMEL, MD, Hopital Beaujon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2014

Primary Completion (Actual)

April 21, 2022

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimated)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APACaP D13-1
  • 2014-A00228-39 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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