A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer

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

Inclusion Criteria:

Patients who were to undergo either of the following procedures

• partial (external approach) or total laryngectomy
• partial pharyngectomy with primary closure or free-flap reconstruction
• total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction)
• oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap

Exclusion Criteria:

Patients with

• malabsorption syndromes
• primary immune disorders
• active infection on presentation
• patients undergoing secondary surgical reconstruction
• patients undergoing palliative surgery
• patients aged under 18 years old
• patients who were pregnant or breast feeding