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

S Ghosh, G Dempsey, R Skelly, R J Shaw, Simon N Rogers, D Lowe, T M Jones

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5 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)107-114
Journale-SPEN Journal: The European e-Journal of Clinical Nutrition and Metabolism
Volume7
Issue number3
DOIs
Publication statusPublished - Jun 2012

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Phase III Clinical Trials
Enteral Nutrition
Head and Neck Neoplasms
Length of Stay
Placebos
Mortality
Omega-3 Fatty Acids
Infection
Coinfection
Ambulatory Surgical Procedures
Arginine
Nucleotides
Randomized Controlled Trials
Control Groups
Carcinoma, squamous cell of head and neck

Cite this

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title = "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 = "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.",
author = "S Ghosh and G Dempsey and R Skelly and Shaw, {R J} and Rogers, {Simon N} and D Lowe and Jones, {T M}",
year = "2012",
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language = "English",
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pages = "107--114",
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TY - JOUR

T1 - 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

AU - Ghosh, S

AU - Dempsey, G

AU - Skelly, R

AU - Shaw, R J

AU - Rogers, Simon N

AU - Lowe, D

AU - Jones, T M

PY - 2012/6

Y1 - 2012/6

N2 - 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.

AB - 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.

U2 - 10.1016/j.clnme.2011.12.001

DO - 10.1016/j.clnme.2011.12.001

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