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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of Mouth, Squamous Cell Carcinoma of Oropharynx, Laryngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Hypopharynx

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Systemic infection

Outcome Description:

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

Outcome Time Frame:

30 days post surgery

Safety Issue:

No

Principal Investigator

Terence M Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Liverpool

Authority:

United Kingdom: National Health Service

Study ID:

EC.73.03

NCT ID:

NCT01314755

Start Date:

November 2003

Completion Date:

July 2008

Related Keywords:

  • Squamous Cell Carcinoma of Mouth
  • Squamous Cell Carcinoma of Oropharynx
  • Laryngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Hypopharynx
  • Head and Neck neoplasm
  • Nutrition
  • Carcinoma
  • Infection
  • Post-operative
  • Surgery
  • Immune-enhancing
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms

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