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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314755
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Information provided by:
Liverpool University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314755

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

Additional Information:
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Responsible Party: Terence M Jones, University of Liverpool, University Hospital Aintree, Liverpool, UK Identifier: NCT01314755    
Other Study ID Numbers: EC.73.03
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2008
Keywords provided by Liverpool University Hospitals NHS Foundation Trust:
Head and Neck neoplasm
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site