NCT01314755

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

4.7 years

First QC Date

March 14, 2011

Last Update Submit

August 5, 2020

Conditions

Squamous Cell Carcinoma of MouthSquamous Cell Carcinoma of OropharynxLaryngeal Squamous Cell CarcinomaSquamous Cell Carcinoma of the Hypopharynx

Keywords

Head and Neck neoplasmNutritionCarcinomaInfectionPost-operativeSurgeryImmune-enhancing

Outcome Measures

Primary Outcomes (1)

  • Systemic infection

    Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.

    30 days post surgery

Secondary Outcomes (2)

  • Local/wound site infection

    Within 30 days post-surgery

  • Length of post-operative hospital stay

    Up to 30 days post surgery

Study Arms (2)

immune-enhancing feed IMPACT

EXPERIMENTAL

immune-enhancing feed IMPACT

Dietary Supplement: IMPACT

control arm

ACTIVE COMPARATOR

iso-nitrogenous, iso-caloric control feed

Dietary Supplement: An iso-caloric, iso-nitrogenous control feed

Interventions

IMPACTDIETARY_SUPPLEMENT

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.

immune-enhancing feed IMPACT
An iso-caloric, iso-nitrogenous control feedDIETARY_SUPPLEMENT
control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aintree

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCarcinomaInfections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Study Officials

  • Terence M Jones, MD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

November 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations

GB(1)