A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer (IMPACTHN)
This study has been completed.
Sponsor:
Aintree University Hospitals NHS Foundation Trust
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
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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
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 Hypopharyngeal Neoplasms Laryngeal Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Neoplasms by Site Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013