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You can access this
clinical trial
if you have
Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma or Squamous Cell Carcinoma of the Hypopharynx
and you are
over 18
years old
-
The phase for this study is not defined.
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The 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.

Provided treatments

  • : IMPACT
  • : An iso-caloric, iso-nitrogenous control feed

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01314755. The sponsor of the trial is Terrence Jones and it is looking for 76 volunteers for the current phase.
Official trial 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