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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||317 participants|
|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|
|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)
- 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 ]
- 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 ]
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
|Contact: Pascal HAMMEL, PhDfirstname.lastname@example.org|
|Principal Investigator:||Pascal Hammel, PhD||Hôpital Beaujon|