Effects of concentrated long-chain omega-3 polyunsaturated fatty acid supplementation before radical prostatectomy on prostate cancer proliferation, inflammation, and quality of life: study protocol for a phase IIb, randomized, double-blind, placebo-controlled trial

Table 1 Data collection schedule

	Initial visit	Randomization	RP	Post-RP follow-up
	Eligibility	Intervention (baseline - V0)	V1	V2 3 mo	V3 6 mo	V4 9 mo	V5 12 mo
Consent		X
Medical history and health behaviors		X
Concomitant medication/symptom evaluation		X		X	X	X	X
Consultation with uro-oncologist	X			X*	X*	X*	X*
Blood sample including total PSA and lipid profile		X	X	X	X	X	X
Digital rectal exam and urine sample		X
Radical prostatectomy (RP)			X
Food frequency questionnaire - FFQ online		X					X
Prostate specific quality of life (IPSS and EPIC-26)		X		X	X	X	X
Hospital Anxiety and Depression Scale (HADS)		X		X	X	X	X
Quality of life (sleep quality, fatigue, cognitive functioning) (ISI, ISF, FACT-COG V3)		X		X	X	X	X
General health and wellbeing (SF-36)		X		X	X	X	X
Fear of recurrence (FCRI)		X		X	X	X	X
Self-reported sleep diary		X	X	X	X	X	X
Therapeutic expectation questionnaire				X			X
Anthropometric measurements^¶		X					X
Vital signs^£		X		X	X	X	X

RP: Radical Prostatectomy; V: visit; mo: months; PSA: Prostate Specific Antigen; IPSS: International Prostate Symptoms Score; EPIC: Expanded Prostate Index Composite; HADS: Hospital Anxiety and Depression Scale; ISI: Insomnia Severity Index; FSI: Fatigue Symptoms Inventory; Fatigue Symptoms Inventory and Functional Assessment of Cancer Therapy – Cognitive Function (FACT-COGv3); SF-36: Short-Form Health Survey; FCRI: Fear of Recurrence Inventory
*The consultation with the urologist might be on a different day but at the same period
^¶Height, weight, hip and waist circumference, body fat measured by skinfold caliper
^£Temperature, blood pressure and pulse

ISSN: 1471-2407