Background
Current knowledge about physical activity in cancer patients
Epidemiology and management of pancreatic ductal adenocarcinoma (PDAC)
Hypothesis for beneficial effects of exercise intervention in patients with advanced PDAC
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Obesity and type II diabetes (metabolic syndrome) are risk factors for PDAC (relative risk [RR] = 1.2–1.6 and 1.8–2.0, respectively) and physical activity may have a protective effect (RR = 0.72),
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Metformin, a drug that decreases insulin resistance, reduces the risk of developing PDAC in in vivo preclinical studies and in observational clinical studies of patients with type II diabetes,
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Insulin receptor is overexpressed in PDAC, and insulin and IGF-1 stimulate proliferation of PDAC cells in vitro,
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Some polymorphisms of IGF, IGF receptor, and IGF-binding protein are associated with an increased risk of PDAC and shorter survival in PDAC patients,
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Weight loss, impaired glucose tolerance and diabetes, along with peripheral insulin resistance are frequently observed in PDAC patients.
Specificities of advanced PDAC affecting the implementation of the APA program
Methods/design
Study objectives and hypotheses
Design
Patients
Ethics and regulatory considerations
Recruitment and randomization
Study protocol
Control group
Intervention group
Safety
Study endpoints and measures
Primary outcome
Secondary outcomes
Screening visit | Randomization visit | Study visit | End of treatment | Follow-up visit | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D7 | D0 | W2 | W4 | W6 | W8 | W10 | W12 | W14 | W16 | W20 | M6 | M8 | M10 | M12 | M14 | M16 | M18 | M20 | M22 | M24 | |
Informed consent | X | ||||||||||||||||||||
Randomization | X | ||||||||||||||||||||
Inclusion criteria | X | ||||||||||||||||||||
Physical activity partner | X | ||||||||||||||||||||
Physical activity level GPAQ | X | ||||||||||||||||||||
Demographic and clinical data | X | ||||||||||||||||||||
Concomitant treatment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Pathological data | X | ||||||||||||||||||||
Clinician visit | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||
Physical exam | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
ECG | X | ||||||||||||||||||||
Questionnaires | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||
6-minute walking test | X | X | X | X | X | X | X | ||||||||||||||
Maximal strength test | X | X | X | X | X | X | X | ||||||||||||||
Body composition | X | X | X | X | X | X | X | ||||||||||||||
Physical activity level IPAQ | X | X | X | X | X | X | X | ||||||||||||||
Biology tests | |||||||||||||||||||||
Type 1
| X | X | X | X | X | X | X | ||||||||||||||
Type 2
| X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
Type 3
| X | X | |||||||||||||||||||
Biobank (optional)
| X | ||||||||||||||||||||
TAP-CT | X | Xa | X | X | X | X | X | X | X | X | X | X | X | ||||||||
CA-19.9 | X | Xa | X | X | X | X | X | X | X | X | X | X | X | ||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Screening visit | Randomization visit | Study visit | End of treatment | Follow-up visit | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D-7 | D0 | W2 | W4 | W6 | W8 | W10 | W12 | W14 | W16 | W20 | M6 | M8 | M10 | M12 | M14 | M16 | M18 | M20 | M22 | M24 | |
Informed consent | X | ||||||||||||||||||||
Randomization | X | ||||||||||||||||||||
Inclusion criteria | X | ||||||||||||||||||||
Physical activity partner | X | ||||||||||||||||||||
Physical activity level GPAQ | X | ||||||||||||||||||||
Demographic and clinical data | X | ||||||||||||||||||||
Concomitant treatment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Pathological data | X | ||||||||||||||||||||
Clinician visit | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||
APA professional | X | X | (X) | (X) | (X) | (X) | |||||||||||||||
Dietitian | X | X | X | X | X | X | (X) | (X) | (X) | (X) | |||||||||||
Physical exam | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
ECG | X | ||||||||||||||||||||
Questionnaires | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||
6-minute walking test | X | X | X | X | X | X | X | ||||||||||||||
Maximal strength test | X | X | X | X | X | X | X | ||||||||||||||
Body composition | X | X | X | X | X | X | X | ||||||||||||||
Physical activity level IPAQ | X | X | X | X | X | X | X | ||||||||||||||
Biology tests | |||||||||||||||||||||
Type 1
| X | X | X | X | X | X | X | ||||||||||||||
Type 2
| X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
Type 3
| X | X | |||||||||||||||||||
Biobank (optional)
| X | ||||||||||||||||||||
TAP-CT | X | Xa | X | X | X | X | X | X | X | X | X | X | X | ||||||||
CA-19.9 | X | Xa | X | X | X | X | X | X | X | X | X | X | X | ||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |