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

Primary Purpose

Pancreas Cancer, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unsupervised APA program
Supervised APA program
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreas Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de BesançonRecruiting
  • CHU de Brest
  • Hôpital Beaujon
  • Hôpital Henri Mondor
  • Hôpital Edouard HerriotRecruiting
  • Hôpital privé Jean Mermoz
  • CHR d'OrléansRecruiting
  • Hôpital Cochin
  • Institut Mutualiste Montsouris
  • Hôpital Haut-Lévêque
  • CHU de Reims
  • CHU de Rouen
  • Institut Curie
  • Centre Paul Strauss
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Unsupervised APA program

Supervised APA program

Usual care

Arm Description

usual care plus a 6-month unsupervised APA program

usual care plus a 6-month supervised APA program

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2018
Last Updated
November 16, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT03400072
Brief Title
Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Acronym
APACaPOp
Official Title
Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unsupervised APA program
Arm Type
Experimental
Arm Description
usual care plus a 6-month unsupervised APA program
Arm Title
Supervised APA program
Arm Type
Experimental
Arm Description
usual care plus a 6-month supervised APA program
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Unsupervised APA program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised APA program
Intervention Description
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.
Primary Outcome Measure Information:
Title
M6 Health-Related quality of life (HRQoL)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Roldan
Phone
00336 34 46 62 51
Email
nelly.roldan@gercor.com.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Delpeut
Email
christine.delpeut@gercor.com.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD PhD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Hammel, MD PhD
Organizational Affiliation
Hôpital Beaujon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Borg, MD PhD
First Name & Middle Initial & Last Name & Degree
Christophe Borg, MD PhD
Facility Name
CHU de Brest
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Metges, MD
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Metges, MD
First Name & Middle Initial & Last Name & Degree
Yves Eusen, MD
First Name & Middle Initial & Last Name & Degree
Pierre-Guillaume Poureau, MD
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Hammel, MD PhD
First Name & Middle Initial & Last Name & Degree
Pascal Hammel, MD PhD
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD
First Name & Middle Initial & Last Name & Degree
Christophe Tournigand, MD PhD
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Walter, MD
First Name & Middle Initial & Last Name & Degree
Thomas Walter, MD
Facility Name
Hôpital privé Jean Mermoz
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme Desrame, MD
First Name & Middle Initial & Last Name & Degree
Jérôme Desrame, MD
Facility Name
CHR d'Orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Lagasse, MD
First Name & Middle Initial & Last Name & Degree
Jean-Paul Lagasse, MD
Facility Name
Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Gaujoux, MD PhD
First Name & Middle Initial & Last Name & Degree
Sébastien Gaujoux, MD PhD
First Name & Middle Initial & Last Name & Degree
Patricia Thoreux, MD PhD
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Louvet, MD PhD
First Name & Middle Initial & Last Name & Degree
Christophe Louvet, MD PhD
Facility Name
Hôpital Haut-Lévêque
City
Pessac
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Terrebonne, MD
First Name & Middle Initial & Last Name & Degree
Eric Terrebonne, MD
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Bouché, MD PhD
First Name & Middle Initial & Last Name & Degree
Olivier Bouché, MD PhD
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilian Schwarz, MD
First Name & Middle Initial & Last Name & Degree
Lilian Schwarz, MD
Facility Name
Institut Curie
City
Saint-Cloud
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD PhD
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD PhD
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meher Benabdelghani, MD
First Name & Middle Initial & Last Name & Degree
Meher Benabdelghani, MD
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosine Guimbaud, MD PhD
First Name & Middle Initial & Last Name & Degree
Rosine Guimbaud, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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