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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02184663
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Unresectable Locally Advanced Cancer Metastatic Pancreatic Cancer Other: without APA program Other: APA program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Actual Study Start Date : October 15, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care without APA program Other: without APA program
Control Arm : chemotherapy alone

Experimental: standard care with APA program Other: APA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)




Primary Outcome Measures :
  1. Multidimensional Fatigue Inventory - (MFI-20 questionnaire) [ Time Frame: At 16 weeks ]
  2. Quality of life - EORTC Quality of Life Questionnaire C-30 - (EORTC QLQ-30 questionnaire) [ Time Frame: At 16 weeks ]

Secondary Outcome Measures :
  1. Time To deterioration (TTD) [ Time Frame: Up to 24 months ]
  2. Brief Pain Inventory Short form questionnaire [ Time Frame: Up to 24 months ]
  3. Patient depression scale - HADS questionnaire [ Time Frame: Up to 24 months ]
  4. 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)

  5. 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

  6. Number of Adverse events (AE) grade 3 -4 [ Time Frame: up to 24 months ]
  7. Progression free survival (PFS) [ Time Frame: 2 years ]
  8. Overall Survival (OS) [ Time Frame: 2 years ]
  9. Accompanying partner depression scale (HADS questionnaire) [ Time Frame: up to 24 months ]
  10. General state - Performance status OMS [ Time Frame: up to 24 months ]
  11. Fatigue scale (EVA fatigue) [ Time Frame: up to 24 months ]
  12. MFI-20 and EORTC QLQ C-30 evaluation [ Time Frame: at 6, 12 et 24 months ]
  13. medico-economic evaluation [ Time Frame: up to 24 months ]
  14. visual analog scale for pain [ Time Frame: up to 24 months ]
  15. analgesic consumption [ Time Frame: up to 24 months ]
  16. anxiolytic / antidepressant consumption [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184663


Contacts
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Contact: Pascal HAMMEL, PhD +33140875651 pascal.hammel@bjn.aphp.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Principal Investigator: Pascal Hammel, PhD Hôpital Beaujon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02184663    
Other Study ID Numbers: APACaP D13-1
2014-A00228-39 ( Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
Unresectable
Pancreatic cancer
GERCOR
Adapted physical activity (APA)
Quality of life
Fatigue
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases