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

This study has been completed.
Sponsor:
Collaborator:
Nestlé Nutrition
Information provided by:
Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01314755
First received: March 14, 2011
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.


Secondary Outcome Measures:
  • Local/wound site infection [ Time Frame: Within 30 days post-surgery ] [ Designated as safety issue: No ]
  • Length of post-operative hospital stay [ Time Frame: Up to 30 days post surgery ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314755

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

Additional Information:
No publications provided

Responsible Party: Terence M Jones, University of Liverpool, University Hospital Aintree, Liverpool, UK
ClinicalTrials.gov Identifier: NCT01314755     History of Changes
Other Study ID Numbers: EC.73.03
Study First Received: March 14, 2011
Last Updated: March 14, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Aintree University Hospitals NHS Foundation Trust:
Head and Neck neoplasm
Nutrition
Carcinoma
Infection
Post-operative
Surgery
Immune-enhancing

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014