- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01314755
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer (IMPACTHN)
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
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Liverpool, Merseyside, United Kingdom, L9 7AL
- University Hospital Aintree
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: immune-enhancing feed 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
iso-nitrogenous, iso-caloric control feed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic infection
Time Frame: 30 days post surgery
|
Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
|
30 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local/wound site infection
Time Frame: Within 30 days post-surgery
|
Local/wound site infection
|
Within 30 days post-surgery
|
Length of post-operative hospital stay
Time Frame: Up to 30 days post surgery
|
Length of post-operative hospital stay
|
Up to 30 days post surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Terence M Jones, MD, University of Liverpool
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC.73.03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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