- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2014-11-20
2022-04-21
2023-12-30
313
NCT02184663
GERCOR - Multidisciplinary Oncology Cooperative Group
GERCOR - Multidisciplinary Oncology Cooperative Group
INTERVENTIONAL
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable 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
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-07-02 | N/A | 2023-09-26 |
2014-07-08 | N/A | 2023-09-28 |
2014-07-09 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Basic Science
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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) | OTHER: without APA program
|
| 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 wi | OTHER: APA program
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Health-related quality of life (HRQoL) 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 | Measure Description | Time Frame |
|---|---|---|
| Time To deterioration (TTD) | Up to 24 months | |
| Brief Pain Inventory Short form questionnaire | Up to 24 months | |
| Patient depression scale - HADS questionnaire | Up to 24 months | |
| Nutritional status evaluation | 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 | 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 | up to 24 months | |
| Progression free survival (PFS) | 2 years | |
| Overall Survival (OS) | 2 years | |
| Accompanying partner depression scale (HADS questionnaire) | up to 24 months | |
| General state - Performance status OMS | up to 24 months | |
| Fatigue scale (EVA fatigue) | up to 24 months | |
| MFI-20 and EORTC QLQ C-30 evaluation | at 6, 12 et 24 months | |
| medico-economic evaluation | up to 24 months | |
| visual analog scale for pain | up to 24 months | |
| analgesic consumption | up to 24 months | |
| anxiolytic / antidepressant consumption | up to 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
