Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
NCT ID: NCT02184663
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
313 participants
INTERVENTIONAL
2014-11-20
2023-12-30
Brief Summary
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Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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)
* Nutritional, psychological and pain management as recommended, according to the usual schedule.
without APA program
Control Arm : chemotherapy alone
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 with a family member or friend (APA partner).
APA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Interventions
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without APA program
Control Arm : chemotherapy alone
APA program
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Responsible Party
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Principal Investigators
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Pascal Hammel, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Beaujon
Locations
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Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CHU Morvan
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
Countries
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References
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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.
Other Identifiers
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2014-A00228-39
Identifier Type: OTHER
Identifier Source: secondary_id
APACaP D13-1
Identifier Type: -
Identifier Source: org_study_id
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