The impact of perioperative administration of seasonal influenza vaccine and arginine-enriched immunonutrition on perioperative immune status (PaSIVI): A Feasibility and Pilot Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: This randomised control trial will include participants undergoing abdominopelvic cancer surgery only Arm 1: Control ‐ no intervention Arm 2: Influenza vaccine only: 1. Seasonal quadrivalent influenza vaccine, 0.5mL ‐ administered 1 day prior to abdomino‐pelvic cancer surgery or on day of surgery, administered by doctor. Arm 3: Influenza vaccine and arginine immunonutrition: 1. Seasonal quadrivalent influenza vaccine, 0.5mL ‐ administered 1 day prior to abdomino‐pelvic cancer surgery or on day of surgery, adminsitered by doctor. 2. Dietary supplementation of oral arginine ‐ 4.5g twice daily (powder to be diluted in 200ml water), prescribed 5 days before and after surgery CONDITION: Surgery ‐ Other surgery Cancer ‐ Any cancer Cancer Surgery;Perioperative immunosuppression; ; Cancer Surgery ; Perioperative immunosuppression PRIMARY OUTCOME: To characterise the effect of influenza vaccine and immunonutrition on perioperative natural killer cell activity[Natural kill cell activity, in ex‐vivo assays from participant blood collected at baseline, pre‐induction of anaesthesia, postoperative days 1, 3 and 5.] To characterise the effect of influenza vaccine and immunonutrition on perioperative natural killer cell number; [Natural kill cell number, in ex‐vivo assays from participant blood collected at baseline, pre‐induction of anaesthesia, postoperative days 1, 3 and 5.] SECONDARY OUTCOME: To measure the rate of recruitment of eligible patients into the study by audit of screening logs for the study.[Cumulative data will be assessed at the end of the 24month recruitment period ; ] Feasibility will be assessed as successful delivery of the randomised treatment arm in 90% participants, to be measured by audit of electronic study records in which study treatment of subjects will be recorded[Cumulative data will be assessed at the end of the 24month recruitment period ; ] INCLUSION CRITERIA: INCLUSION CRITERIA: • Male or female • Age >18 years. • Elective surgery • Major intra‐abdominal cancer surgery, including: o Colorectal o Sarcoma o Upper gastrointestinal o Hepatobiliary o Genitourinary
Epistemonikos ID: cba42521f002f892d05e4efd4660d833875e5902
First added on: Aug 25, 2024