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

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma of the Hypopharynx; Squamous Cell Carcinoma of Oropharynx; Laryngeal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Mouth
• Interventions: Dietary Supplement: An iso-caloric, iso-nitrogenous control feed; Dietary Supplement: IMPACT

• Registration Number: NCT01314755
• Lead Sponsor: Terrence Jones

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

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	An iso-caloric, iso-nitrogenous control feed	iso-nitrogenous, iso-caloric control feed
immune-enhancing feed IMPACT	IMPACT	immune-enhancing feed IMPACT

Primary Outcome Measures

Name	Time	Method
Systemic infection	30 days post surgery	Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.

Secondary Outcome Measures

Name	Time	Method
Local/wound site infection	Within 30 days post-surgery	Local/wound site infection
Length of post-operative hospital stay	Up to 30 days post surgery	Length of post-operative hospital stay

Trial Locations

Locations (1)

University Hospital Aintree; 🇬🇧 Liverpool, Merseyside, United Kingdom