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

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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

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 9, 2014
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE October 15, 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
  • Multidimensional Fatigue Inventory - (MFI-20 questionnaire) [ Time Frame: At 16 weeks ]
  • Quality of life - EORTC Quality of Life Questionnaire C-30 - (EORTC QLQ-30 questionnaire) [ Time Frame: At 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Multidimensional Fatigue Inventory - (MFI-20 questionnaire) [ Time Frame: up to 16 weeks ]
  • Quality of life - EORTC Quality of Life Questionnaire C-30 - (EORTC QLQ-30 questionnaire) [ Time Frame: Up to 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
  • Time To deterioration (TTD) [ Time Frame: Up to 24 months ]
  • Brief Pain Inventory Short form questionnaire [ Time Frame: Up to 24 months ]
  • Patient depression scale - HADS questionnaire [ Time Frame: 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)
  • 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
  • Number of Adverse events (AE) grade 3 -4 [ Time Frame: up to 24 months ]
  • Progression free survival (PFS) [ Time Frame: 2 years ]
  • Overall Survival (OS) [ Time Frame: 2 years ]
  • Accompanying partner depression scale (HADS questionnaire) [ Time Frame: up to 24 months ]
  • General state - Performance status OMS [ Time Frame: up to 24 months ]
  • Fatigue scale (EVA fatigue) [ Time Frame: up to 24 months ]
  • MFI-20 and EORTC QLQ C-30 evaluation [ Time Frame: at 6, 12 et 24 months ]
  • medico-economic evaluation [ Time Frame: up to 24 months ]
  • visual analog scale for pain [ Time Frame: up to 24 months ]
  • analgesic consumption [ Time Frame: up to 24 months ]
  • anxiolytic / antidepressant consumption [ Time Frame: up to 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Time To deterioration (TTD) [ Time Frame: Up to 24 months ]
  • Brief Pain Inventory Short form questionnaire [ Time Frame: Up to 24 months ]
  • depression scale - (HADS questionnaire) [ Time Frame: Up to 24 months ]
  • Body Mass Index [ Time Frame: up to 24 months ]
  • International Physical Activity Questionnaire - (IPAQ questionnaire) [ Time Frame: up to 24 months ]
  • Number of Adverse events (AE) grade 3 -4 [ Time Frame: up to 24 months ]
  • Progression free survival (PFS) [ Time Frame: 2 years ]
  • Overall Survival (OS) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
Official Title  ICMJE Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Unresectable Locally Advanced Cancer
  • Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Other: without APA program
    Control Arm : chemotherapy alone
  • Other: APA program
    Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Study Arms  ICMJE
  • Active Comparator: Standard care without APA program
    Intervention: Other: without APA program
  • Experimental: standard care with APA program
    Intervention: Other: APA program
Publications * Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
317
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
200
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pascal HAMMEL, PhD +33140875651 pascal.hammel@bjn.aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02184663
Other Study ID Numbers  ICMJE APACaP D13-1
2014-A00228-39 ( Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GERCOR - Multidisciplinary Oncology Cooperative Group
Study Sponsor  ICMJE GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pascal Hammel, PhD Hôpital Beaujon
PRS Account GERCOR - Multidisciplinary Oncology Cooperative Group
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP