Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial (APACaPOp)

November 16, 2018 updated by: Centre Hospitalier Universitaire de Besancon

Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.

This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

252

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 Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besancon
        • Contact:
          • Christophe Borg, MD PhD
        • Principal Investigator:
          • Christophe Borg, MD PhD
      • Brest, France
        • Not yet recruiting
        • CHU de Brest
        • Contact:
          • Jean-Philippe Metges, MD
        • Sub-Investigator:
          • Yves Eusen, MD
        • Sub-Investigator:
          • Pierre-Guillaume Poureau, MD
      • Clichy, France
        • Not yet recruiting
        • Hôpital Beaujon
        • Contact:
          • Pascal Hammel, MD PhD
        • Principal Investigator:
          • Pascal Hammel, MD PhD
      • Créteil, France
        • Not yet recruiting
        • Hopital Henri Mondor
        • Principal Investigator:
          • Christophe Tournigand, MD PhD
        • Sub-Investigator:
          • Cindy Neuzillet, MD
      • Lyon, France
        • Not yet recruiting
        • Hopital Privé Jean Mermoz
      • Lyon, France
        • Recruiting
        • Hopital Edouard Herriot
      • Orléans, France
        • Recruiting
        • CHR d'Orleans
        • Contact:
          • Jean-Paul LAGASSE, MD
        • Principal Investigator:
          • Jean-Paul Lagasse, MD
      • Paris, France
        • Not yet recruiting
        • Institut Mutualiste Montsouris
      • Paris, France
        • Not yet recruiting
        • Hopital Cochin
        • Contact:
          • Sébastien Gaujoux, MD PhD
        • Principal Investigator:
          • Sébastien Gaujoux, MD PhD
        • Sub-Investigator:
          • Patricia Thoreux, MD PhD
      • Pessac, France
        • Not yet recruiting
        • Hôpital Haut-Lévêque
        • Contact:
          • Eric TERREBONNE, MD
        • Principal Investigator:
          • Eric TERREBONNE, MD
      • Reims, France
        • Not yet recruiting
        • Chu de Reims
        • Contact:
          • Olivier Bouché, MD PhD
        • Principal Investigator:
          • Olivier Bouché, MD PhD
      • Rouen, France
        • Not yet recruiting
        • CHU de Rouen
      • Saint-Cloud, France
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Cindy Neuzillet, MD PhD
        • Principal Investigator:
          • Cindy Neuzillet, MD PhD
      • Strasbourg, France
        • Not yet recruiting
        • Centre Paul Strauss
        • Contact:
          • Meher BENABDELGHANI, MD
        • Principal Investigator:
          • Meher Benabdelghani, MD
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:
          • Rosine Guimbaud, MD PhD
        • Principal Investigator:
          • Rosine Guimbaud, MD PhD

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven PDAC
  • Complete macroscopic resection (R0 or R1 resection)
  • Patients randomized within 12 weeks of surgery
  • No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs
  • Sufficient recovery from the operation and fit to take part in the trial
  • Able to attend for administration of the adjuvant CT
  • ECOG PS 0-2
  • Age ≥ 18 years
  • Life expectancy > 3 months
  • Dated and signed informed consent
  • Registration in a national health care system (CMU included).

Exclusion Criteria:

  • Macroscopically remaining tumor (R2 resection or TNM stage IV disease)
  • Histology other than PDAC
  • Cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological condition contra-indicating exercise practice
  • Pregnancy or breastfeeding
  • Protected adults (individuals under guardianship by court order). Note: participation to another concomitant clinical trial is allowed but the patient must inform and get an authorization from the Investigator.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual care
EXPERIMENTAL: Unsupervised APA program
usual care plus a 6-month unsupervised APA program
Other: Unsupervised APA program
Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions.
EXPERIMENTAL: Supervised APA program
usual care plus a 6-month supervised APA program
Other: Supervised APA program
Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions; in addition, patients will attend weekly supervised, hospital-based exercise sessions in groups of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
M6 Health-Related quality of life (HRQoL)
Time Frame: month 6
HRQoL will be assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ) C30 at M6, with the following targeted dimensions: global QoL, fatigue, physical functioning, and pain.
month 6

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Principal Investigator: Cindy Neuzillet, MD PhD, Henri Mondor University Hospital
  • Principal Investigator: Pascal Hammel, MD PhD, Hôpital Beaujon

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)

August 3, 2018

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 9, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2017/317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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