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

Study Overview
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Brief Summary
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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.

Detailed Description
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As above

Official Title
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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

Conditions
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Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Hypopharynx

Intervention / Treatment
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* Dietary Supplement: IMPACT
* Dietary Supplement: An iso-caloric, iso-nitrogenous control feed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immune-enhancing feed IMPACT<br>immune-enhancing feed IMPACT | Dietary Supplement: IMPACT<br>* 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.<br>|
| Active Comparator: control arm<br>iso-nitrogenous, iso-caloric control feed | Dietary Supplement: An iso-caloric, iso-nitrogenous control feed<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic infection | Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological. | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local/wound site infection | Local/wound site infection | Within 30 days post-surgery | 
| Length of post-operative hospital stay | Length of post-operative hospital stay | Up to 30 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck neoplasm, Nutrition, Carcinoma, Infection, Post-operative, Surgery, Immune-enhancing