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

This study has been completed.
Information provided by:
Aintree University Hospitals NHS Foundation Trust Identifier:
First received: March 14, 2011
Last updated: NA
Last verified: March 2008
History: No changes posted

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.

Condition Intervention Phase
Squamous Cell Carcinoma of Mouth Squamous Cell Carcinoma of Oropharynx Laryngeal Squamous Cell Carcinoma Squamous Cell Carcinoma of the Hypopharynx Dietary Supplement: IMPACT Dietary Supplement: An iso-caloric, iso-nitrogenous control feed Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Systemic infection [ Time Frame: 30 days post surgery ]
    Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.

Secondary Outcome Measures:
  • Local/wound site infection [ Time Frame: Within 30 days post-surgery ]
  • Length of post-operative hospital stay [ Time Frame: Up to 30 days post surgery ]

Enrollment: 76
Study Start Date: November 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immune-enhancing feed IMPACT Dietary Supplement: IMPACT
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.
Active Comparator: control arm Dietary Supplement: An iso-caloric, iso-nitrogenous control feed


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01314755

United Kingdom
University Hospital Aintree
Liverpool, Merseyside, United Kingdom, L9 7AL
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Principal Investigator: Terence M Jones, MD University of Liverpool
  More Information

Additional Information:
Responsible Party: Terence M Jones, University of Liverpool, University Hospital Aintree, Liverpool, UK Identifier: NCT01314755     History of Changes
Other Study ID Numbers: EC.73.03
Study First Received: March 14, 2011
Last Updated: March 14, 2011

Keywords provided by Aintree University Hospitals NHS Foundation Trust:
Head and Neck neoplasm

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases processed this record on August 16, 2017