A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer

Laryngeal Squamous Cell Carcinoma Clinical Trial

— IMPACTHN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314755
• Other study ID #: EC.73.03
• Status: Completed
• Phase: N/A
• Start date: November 2003
• Est. completion date: July 2008

Study information

• Verified date: August 2020
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Mouth
• Squamous Cell Carcinoma of Oropharynx
• Squamous Cell Carcinoma of the Hypopharynx

Intervention

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.
• An iso-caloric, iso-nitrogenous control feed

Locations

Country	Name	City	State
United Kingdom	University Hospital Aintree	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Terrence Jones	Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic infection	Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.	30 days post surgery
Secondary	Local/wound site infection	Local/wound site infection	Within 30 days post-surgery
Secondary	Length of post-operative hospital stay	Length of post-operative hospital stay	Up to 30 days post surgery

External Links

•   Aintree Hospital web site
•   Liverpool university web site