Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
2 other identifiers
interventional
313
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedSeptember 28, 2023
September 1, 2023
7.4 years
July 2, 2014
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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
up to 24 months
Physical Activity evaluation - IPAQ questionnaire
up to 24 months
- +11 more secondary outcomes
Study Arms (2)
Standard care without APA program
ACTIVE COMPARATORThe 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.
Standard care with APA program
EXPERIMENTALThe 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).
Interventions
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (1)
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.
PMID: 26458923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascal Hammel, MD
Hôpital Beaujon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 9, 2014
Study Start
November 20, 2014
Primary Completion
April 21, 2022
Study Completion
December 30, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09