Pancreas CancerAPACaPOpNCT03400072
Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
A study testing Unsupervised APA program and Supervised APA program in people with Pancreas Cancer and Quality of Life, run by Centre Hospitalier Universitaire de Besancon at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Quality of Life
- What is being tested?
- Unsupervised APA program and Supervised APA program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 15 sitesFrance
- Study dates
- 3 Aug 2018to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
Christine Delpeut contact
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Christophe Borg, MD PhD
Christophe Borg, MD PhD
- Not yet recruiting
CHU de Brest
Brest
Jean-Philippe Metges, MD
Jean-Philippe Metges, MD
- Not yet recruiting
Hôpital Beaujon
Clichy
Pascal Hammel, MD PhD
Pascal Hammel, MD PhD
- Not yet recruiting
Hôpital Henri Mondor
Créteil
Cindy Neuzillet, MD
Christophe Tournigand, MD PhD
- Recruiting
Hôpital Edouard Herriot
Lyon
Thomas Walter, MD
Thomas Walter, MD
- Not yet recruiting
Hôpital privé Jean Mermoz
Lyon
Jérôme Desrame, MD
Jérôme Desrame, MD
- Recruiting
CHR d'Orléans
Orléans
Jean-Paul Lagasse, MD
Jean-Paul Lagasse, MD
- Not yet recruiting
Hôpital Cochin
Paris
Sébastien Gaujoux, MD PhD
Sébastien Gaujoux, MD PhD
- Not yet recruiting
Institut Mutualiste Montsouris
Paris
Christophe Louvet, MD PhD
Christophe Louvet, MD PhD
- Not yet recruiting
Hôpital Haut-Lévêque
Pessac
Eric Terrebonne, MD
Eric Terrebonne, MD
- Not yet recruiting
CHU de Reims
Reims
Olivier Bouché, MD PhD
Olivier Bouché, MD PhD
- Not yet recruiting
CHU de Rouen
Rouen
Lilian Schwarz, MD
Lilian Schwarz, MD
- Not yet recruiting
Institut Curie
Saint-Cloud
Cindy Neuzillet, MD PhD
Cindy Neuzillet, MD PhD
- Not yet recruiting
Centre Paul Strauss
Strasbourg
Meher Benabdelghani, MD
Meher Benabdelghani, MD
- Not yet recruiting
CHU de Toulouse
Toulouse
Rosine Guimbaud, MD PhD
Rosine Guimbaud, MD PhD
About this study
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).
- Conditions
- Pancreas Cancer, Quality of Life
- Being tested
- Unsupervised APA program, Supervised APA program
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsupervised APA programOther
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.
Supervised APA programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Unsupervised APA program | Experimental | usual care plus a 6-month unsupervised APA program Receives: Other: Unsupervised APA program |
| Supervised APA program | Experimental | usual care plus a 6-month supervised APA program Receives: Other: Supervised APA program |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start3 Aug 2018
- Primary completionFeb 2022 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Responsible party
- Sponsor
- Investigators
- Cindy Neuzillet, MD PhD, Principal investigator, Henri Mondor University HospitalPascal Hammel, MD PhD, Principal investigator, Hôpital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400072
- Sponsor's protocol ID
- P/2017/317
- Acronym
- APACaPOp
- Status last verified
- Nov 2018
- First submitted
- 9 Jan 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT03400072
- Acronym / sponsor ID
- APACaPOp / P/2017/317
- Conditions
- Pancreas Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unsupervised APA program | Experimental | Other: Unsupervised APA programusual care plus a 6-month unsupervised APA program |
| Supervised APA program | Experimental | Other: Supervised APA programusual care plus a 6-month supervised APA program |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unsupervised APA programExercise 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. | Other | Unsupervised APA program |
| Supervised APA programExercise 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. | Other | Supervised APA program |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Delpeut contact
Cindy Neuzillet, MD PhD principal investigator
Henri Mondor University Hospital
Pascal Hammel, MD PhD principal investigator
Hôpital Beaujon
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsupervised APA program and Supervised APA program in people with Pancreas Cancer and Quality of Life, run by Centre Hospitalier Universitaire de Besancon at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nelly Roldan (00336 34 46 62 51, nelly.roldan@gercor.com.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M6 Health-Related quality of life (HRQoL) (time frame: month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.