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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2024-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pancreas Cancer Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unsupervised APA program

usual care plus a 6-month unsupervised APA program

Group Type EXPERIMENTAL

Unsupervised APA program

Intervention Type OTHER

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 program

usual care plus a 6-month supervised APA program

Group Type EXPERIMENTAL

Supervised APA program

Intervention Type OTHER

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.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cindy Neuzillet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Pascal Hammel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Beaujon

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING