Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

September 26, 2023 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.

The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.

200 randomized patients are required.

The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
313

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Brest, France
        • CHU Morvan
      • Clichy, France
        • Hopital Beaujon
      • Creteil, France
        • Hôpital Henri Mondor
      • Dijon, France
        • Centre Georges François Leclerc
      • La Roche Sur Yon, France
        • CHD Vendee
      • Levallois Perret, France
        • Institut hospitalier franco-britannique
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • CH Saint Joseph Saint Luc
      • Marseille, France
        • Hopital Europeen
      • Mont de Marsan, France
        • CH Mont de Marsan
      • Montbéliard, France
        • Centre Hospitalier de Belfort
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hopital Cochin
      • Reims, France
        • CHU Robert Debré
      • Suresnes, France
        • Hopital Foch
      • Vandoeuvre Les Nancy, France
        • Institut de Cancerologie de Lorraine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven non resectable pancreatic adenocarcinoma
  • Indication of palliative chemotherapy
  • Life expectancy ≥ 3 months
  • Eastern Cooperative oncology group (ECOG) - Performance status ≤2
  • Age ≥18 years old
  • At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
  • Identified Accompanying partner Adapted Physical Activity (AAPA)
  • Signed and dated informed consent
  • Registration in a National Health Care System (CMU included for France)

Exclusion Criteria:

  • Previous Cerebrovascular accident or myocardial infarction <6months
  • Uncontrolled hypertension.
  • Severe cardiovascular or respiratory disease
  • Severe cognitive or psychiatric disorder
  • Severe motor and/or sensory neuropathy
  • Rheumatologic or orthopedic problem or bone lesions with a fracture risk
  • Others comorbidities contra-indicated physical exercises
  • Patient protected by the law - Guardianship and trusteeship

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard care without APA program

The control arm corresponds to usual care (without APA), including :

  • Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol)
  • Evaluation by the oncologist at the usual rate
  • Assessment every 8 weeks (TAP scan + CA-19.9)
  • Nutritional, psychological and pain management as recommended, according to the usual schedule.
Other: without APA program
Control Arm : chemotherapy alone
Experimental: Standard care with APA program

The experimental arm corresponds to usual care, combined with a 16-week APA program.

The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner).
Other: APA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQoL) at 16 weeks
Time Frame: At 16 weeks
HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.
At 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 2 years
2 years
Progression free survival (PFS)
Time Frame: 2 years
2 years
Time To deterioration (TTD)
Time Frame: Up to 24 months
Up to 24 months
Brief Pain Inventory Short form questionnaire
Time Frame: Up to 24 months
Up to 24 months
Patient depression scale - HADS questionnaire
Time Frame: Up to 24 months
Up to 24 months
Nutritional status evaluation
Time Frame: up to 24 months
Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)
up to 24 months
Physical Activity evaluation - IPAQ questionnaire
Time Frame: up to 24 months
Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program
up to 24 months
Number of Adverse events (AE) grade 3 -4
Time Frame: up to 24 months
up to 24 months
Accompanying partner depression scale (HADS questionnaire)
Time Frame: up to 24 months
up to 24 months
General state - Performance status OMS
Time Frame: up to 24 months
up to 24 months
Fatigue scale (EVA fatigue)
Time Frame: up to 24 months
up to 24 months
MFI-20 and EORTC QLQ C-30 evaluation
Time Frame: at 6, 12 et 24 months
at 6, 12 et 24 months
medico-economic evaluation
Time Frame: up to 24 months
up to 24 months
visual analog scale for pain
Time Frame: up to 24 months
up to 24 months
analgesic consumption
Time Frame: up to 24 months
up to 24 months
anxiolytic / antidepressant consumption
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascal HAMMEL, MD, Hopital Beaujon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APACaP D13-1
  • 2014-A00228-39 (Other Identifier: ANSM)

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.

Clinical Trials on Metastatic Pancreatic Cancer

Clinical Trials on without APA program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings