A double blind, randomised, placebo controlled, feasibility phase III clinical trial of peri-operative immune-enhancing enteral nutrition in patients undergoing surgery for advanced head and neck cancer

Abstract

Summary Background & aims Conflicting evidence exists as to whether post-operative infections in patients with Squamous Cell carcinoma of the Head and Neck (SCCHN) are reduced by peri-operative enteral feeding with immune-enhancing feeds such as Impact, which contains l -arginine, nucleotides and omega-3 fatty acids. Our study aimed to address this conflict. Methods We conducted a single centre, double blind, randomised, placebo controlled, clinical trial. Patients undergoing surgery for SCCHN were fed enterally with either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery. The rates of systemic and local infective complications, length of hospital stay and peri-operative mortality rates were compared between the two groups. Results Data for analysis were available for 57 patients; 28 who received IMPACT and 29 the control feed. A primary infection occurred in 35% (20/57) of patients; 43% (12/28) in the Impact group and 28% (8/29) in the control group, (P = 0.27, Fishers Exact test). No differences in secondary infection rates or length of hospital stay were observed between the groups. Conclusions In this under-powered study, peri-operative use of Impact in patients undergoing surgery for SCCHN did not lead to significant differences in infective complications, length of hospital stay or peri-operative mortality. Larger studies are required.