Laryngeal Squamous Cell Carcinoma Clinical Trial
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
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.
As above ;
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