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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00228-39 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care without APA program | Active Comparator | The control arm corresponds to usual care (without APA), including :
|
|
| Standard care with APA program | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| without APA program | Other | Control Arm : chemotherapy alone |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Hammel, MD | Hôpital Beaujon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | France | ||||
| CHU Morvan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26458923 | Derived | Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8. |
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| APA program |
| Other |
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises) |
|
| 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 |
| Brest |
| France |
| Hôpital Beaujon | Clichy | France |
| Hôpital Henri Mondor | Créteil | France |
| Centre Georges François Leclerc | Dijon | France |
| CHD Vendée | La Roche-sur-Yon | France |
| Institut Hospitalier Franco-Britannique | Levallois-Perret | France |
| Centre Léon Bérard | Lyon | France |
| CH Saint Joseph Saint Luc | Lyon | France |
| Hôpital Européen | Marseille | France |
| CH Mont de Marsan | Mont-de-Marsan | France |
| Centre Hospitalier de Belfort | Montbéliard | France |
| Hôpital Cochin | Paris | France |
| Hôpital Saint Antoine | Paris | France |
| CHU Robert Debré | Reims | France |
| Hôpital FOCH | Suresnes | France |
| Institut de cancérologie de Lorraine | Vandœuvre-lès-Nancy | France |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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