CClinicalTrials.gg
Status unknownNCT03400072APACaPOpUpdated Nov 19, 2018

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

An interventional study of Unsupervised APA program and Supervised APA program in Pancreas Cancer and Quality of Life, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Pancreas Cancer
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (estimated)

Study arms

  • Experimental
    Unsupervised APA program

    usual care plus a 6-month unsupervised APA program

    Other: Unsupervised APA program

  • Experimental
    Supervised APA program

    usual care plus a 6-month supervised APA program

    Other: Supervised APA program

  • No intervention
    Usual care

    Usual care

Interventions

  • OtherUnsupervised 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.

  • OtherSupervised 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.

05

What researchers measure

Primary outcomes

  1. M6 Health-Related quality of life (HRQoL)

    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.

    Time frame: month 6

06

Study locations

3 of 15 sites recruiting
  • CHU de Besançon
    Besançon, 25000, France
    • Christophe Borg, MD PhD · Contact
    • Christophe Borg, MD PhD · Principal investigator
    Recruiting
  • CHU de Brest
    Brest, France
    • Jean-Philippe Metges, MD · Contact
    • Jean-Philippe Metges, MD · Principal investigator
    • Yves Eusen, MD · Sub investigator
    • Pierre-Guillaume Poureau, MD · Sub investigator
    Not yet recruiting
  • Hôpital Beaujon
    Clichy, France
    • Pascal Hammel, MD PhD · Contact
    • Pascal Hammel, MD PhD · Principal investigator
    Not yet recruiting
  • Hôpital Henri Mondor
    Créteil, France
    • Cindy Neuzillet, MD · Contact
    • Christophe Tournigand, MD PhD · Principal investigator
    • Cindy Neuzillet, MD · Sub investigator
    Not yet recruiting
  • Hôpital Edouard Herriot
    Lyon, France
    • Thomas Walter, MD · Contact
    • Thomas Walter, MD · Principal investigator
    Recruiting
  • Hôpital privé Jean Mermoz
    Lyon, France
    • Jérôme Desrame, MD · Contact
    • Jérôme Desrame, MD · Principal investigator
    Not yet recruiting
  • CHR d'Orléans
    Orléans, France
    • Jean-Paul Lagasse, MD · Contact
    • Jean-Paul Lagasse, MD · Principal investigator
    Recruiting
  • Hôpital Cochin
    Paris, France
    • Sébastien Gaujoux, MD PhD · Contact
    • Sébastien Gaujoux, MD PhD · Principal investigator
    • Patricia Thoreux, MD PhD · Sub investigator
    Not yet recruiting
  • Institut Mutualiste Montsouris
    Paris, France
    • Christophe Louvet, MD PhD · Contact
    • Christophe Louvet, MD PhD · Principal investigator
    Not yet recruiting
  • Hôpital Haut-Lévêque
    Pessac, France
    • Eric Terrebonne, MD · Contact
    • Eric Terrebonne, MD · Principal investigator
    Not yet recruiting
  • CHU de Reims
    Reims, France
    • Olivier Bouché, MD PhD · Contact
    • Olivier Bouché, MD PhD · Principal investigator
    Not yet recruiting
  • CHU de Rouen
    Rouen, France
    • Lilian Schwarz, MD · Contact
    • Lilian Schwarz, MD · Principal investigator
    Not yet recruiting
  • Institut Curie
    Saint-Cloud, France
    • Cindy Neuzillet, MD PhD · Contact
    • Cindy Neuzillet, MD PhD · Principal investigator
    Not yet recruiting
  • Centre Paul Strauss
    Strasbourg, France
    • Meher Benabdelghani, MD · Contact
    • Meher Benabdelghani, MD · Principal investigator
    Not yet recruiting
  • CHU de Toulouse
    Toulouse, France
    • Rosine Guimbaud, MD PhD · Contact
    • Rosine Guimbaud, MD PhD · Principal investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03400072
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Aug 3, 2018
Primary completion
Feb 2022 (estimated)
Completion
Aug 2024 (estimated)
Last update
Nov 19, 2018

Study contacts

Nelly Roldan
Contact
nelly.roldan@gercor.com.fr
00336 34 46 62 51
Christine Delpeut
Contact
christine.delpeut@gercor.com.fr
Cindy Neuzillet, MD PhD
principal investigator · Henri Mondor University Hospital
Pascal Hammel, MD PhD
principal investigator · Hôpital Beaujon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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