Trials / Completed
CompletedNCT01314755
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Terrence Jones · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
As above
Conditions
- Squamous Cell Carcinoma of Mouth
- Squamous Cell Carcinoma of Oropharynx
- Laryngeal Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Hypopharynx
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | An iso-caloric, iso-nitrogenous control feed |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2011-03-15
- Last updated
- 2020-08-07
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01314755. Inclusion in this directory is not an endorsement.