A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
NCT ID: NCT01314755
Last Updated: 2020-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2003-11-30
2008-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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immune-enhancing feed IMPACT
immune-enhancing feed IMPACT
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.
control arm
iso-nitrogenous, iso-caloric control feed
An iso-caloric, iso-nitrogenous control feed
Interventions
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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.
An iso-caloric, iso-nitrogenous control feed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Terrence Jones
OTHER_GOV
Responsible Party
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Terrence Jones
Professor
Principal Investigators
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Terence M Jones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool
Locations
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University Hospital Aintree
Liverpool, Merseyside, United Kingdom
Countries
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Other Identifiers
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EC.73.03
Identifier Type: -
Identifier Source: org_study_id
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