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

Primary Purpose

Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
IMPACT
An iso-caloric, iso-nitrogenous control feed
Sponsored by
Terrence Jones
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Mouth focused on measuring Head and Neck neoplasm, Nutrition, Carcinoma, Infection, Post-operative, Surgery, Immune-enhancing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aintree

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immune-enhancing feed IMPACT

control arm

Arm Description

immune-enhancing feed IMPACT

iso-nitrogenous, iso-caloric control feed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local/wound site infection
Local/wound site infection
Length of post-operative hospital stay
Length of post-operative hospital stay

Full Information

First Posted
March 14, 2011
Last Updated
August 5, 2020
Sponsor
Terrence Jones
Collaborators
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01314755
Brief Title
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Terrence Jones
Collaborators
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
As above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Hypopharynx
Keywords
Head and Neck neoplasm, Nutrition, Carcinoma, Infection, Post-operative, Surgery, Immune-enhancing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
either Impact or an iso-nitrogenous, iso-caloric control feed for five days pre and seven days post-surgery
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immune-enhancing feed IMPACT
Arm Type
Experimental
Arm Description
immune-enhancing feed IMPACT
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
iso-nitrogenous, iso-caloric control feed
Intervention Type
Dietary Supplement
Intervention Name(s)
IMPACT
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
An iso-caloric, iso-nitrogenous control feed
Primary Outcome Measure Information:
Title
Systemic infection
Description
Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
Local/wound site infection
Description
Local/wound site infection
Time Frame
Within 30 days post-surgery
Title
Length of post-operative hospital stay
Description
Length of post-operative hospital stay
Time Frame
Up to 30 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence M Jones, MD
Organizational Affiliation
University of Liverpool
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aintree
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7AL
Country
United Kingdom

12. IPD Sharing Statement

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

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