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Completed

NCT Number: NCT01314755

A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for 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.

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Key information

Conditions

Squamous Cell Carcinoma of Mouth Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Infections Laryngeal Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of Oropharynx Squamous Cell Carcinoma of the Hypopharynx

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Aintree

Liverpool, Merseyside, L9 7AL, United Kingdom

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMPACT

Dietary Supplement

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.

An iso-caloric, iso-nitrogenous control feed

Dietary Supplement

Primary outcomes

  1. Systemic infection

    Time frame: 30 days post surgery

    Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.

Secondary outcomes

  1. Local/wound site infection

    Time frame: Within 30 days post-surgery

    Local/wound site infection

  2. Length of post-operative hospital stay

    Time frame: Up to 30 days post surgery

    Length of post-operative hospital stay

Sponsors and collaborators

Lead sponsor

Terrence Jones

Other Gov

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study 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

Acronym: IMPACTHN

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Mar 15, 2011
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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