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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01314755

Acronym

IMPACTHN

Enrollment

Registered

2011-03-15

Start date

2003-11-30

Completion date

2008-07-31

Last updated

2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DIETARY_SUPPLEMENTIMPACT

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.

DIETARY_SUPPLEMENTAn iso-caloric, iso-nitrogenous control feed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026