Clinical trial NCT01314755: A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinoma of Mouth
Squamous Cell Carcinoma of Oropharynx
Laryngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Hypopharynx
Keywords: Head and Neck neoplasm
Nutrition
Carcinoma
Infection
Post-operative
Surgery
Immune-enhancing
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2011-03-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
Primary purpose: TREATMENT

Brief summary: 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: As above

Eligibility criteria: 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

Primary outcomes:
measure: Systemic infection
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Local/wound site infection
timeFrame: Within 30 days post-surgery
measure: Length of post-operative hospital stay
timeFrame: Up to 30 days post surgery
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Terence M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: