A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer (IMPACTHN)
Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).
Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. One group will receive IMPACT, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate blinding. Primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. Follow-up will be for 30 days postsurgery.
Squamous Cell Carcinoma of Mouth
Squamous Cell Carcinoma of Oropharynx
Laryngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Hypopharynx
Dietary Supplement: IMPACT
Dietary Supplement: An iso-caloric, iso-nitrogenous control feed
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double Blind, Randomised, Placebo Controlled, Feasibility Phase III Clinical Trial of Peri-operative Immune-enhancing Feed in Patients Undergoing Surgery for Advanced Head and Neck Cancer|
- Systemic infection [ Time Frame: 30 days post surgery ] [ Designated as safety issue: No ]Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
- Local/wound site infection [ Time Frame: Within 30 days post-surgery ] [ Designated as safety issue: No ]
- Length of post-operative hospital stay [ Time Frame: Up to 30 days post surgery ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Experimental: immune-enhancing feed IMPACT||
Dietary Supplement: IMPACT
IMPACT (Nestlé Healthcare Nutrition, Minnetonka, MN, USA) an `immune-enhancing` feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.
|Active Comparator: control arm||Dietary Supplement: An iso-caloric, iso-nitrogenous control feed|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314755
|University Hospital Aintree|
|Liverpool, Merseyside, United Kingdom, L9 7AL|
|Principal Investigator:||Terence M Jones, MD||University of Liverpool|