Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial

Table 1 Schedule of visits and measures in the control arm

	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					X^a				X		X	X	X	X	X	X	X	X	X	X
CA-19.9	X					X^a				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

CA 19–9 carbohydrate antigen 19–9, CRP C-reactive protein, GPAQ Global Physical Activity Questionnaire, HbA1c glycated hemoglobin, HOMA homeostasis model assessment, IGF-1 insulin-like growth factor 1, IPAQ International Physical Activity Questionnaire, TAP-CT thoraco-abdominopelvic computed tomography
^aA +/− 2-week time interval is considered as acceptable
Biology tests - type 1: blood cell count, CRP, fasting glucose, HbA1c, insulin/HOMA, IGF-1, albumin, prealbumin
Biology tests - type 2: blood cell count, CRP, fasting glucose, albumin, prealbumin
Biology tests - type 3: blood cell count, CRP, fasting glucose, insulin/HOMA, IGF-1, albumin, prealbumin
X: to be performed at this timepoint

ISSN: 1745-6215