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The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study


N/A
18 Years
80 Years
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study


This project is in keeping with the strategy of the anaesthetic and intensive care
departments to push towards greater understanding of the immune, metabolic and inflammatory
changes associated with surgery and how these may be modified through use of different
anaesthetic and intensive care techniques. Through increased understanding of the stress,
inflammatory and immune responses to surgery we may be able to modulate peri-operative care
to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence
micrometastatic spread at the time of surgery in future studies.


Inclusion Criteria:



- Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery.

- Royal Marsden Hospital patients with head and neck cancer - all histological
sub-types.

- Capable of providing informed consent

- Age >17

- American Society of Anaesthesiologists Classification I-III.

Exclusion Criteria:

- Past history of ipsilateral neck dissection.

- Bilateral neck dissection

- A recent course of systemic steroids (< 3 months)

- Pregnancy

- Involvement in drug trials

- On following medications: Interleukins, Interferons, Immunosuppressants and long term
opiates

- Recent Synacthen Test (within 48 hours)

- Emergency surgery

- American Society of Anaesthesiologists Classification IV-V.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.

Safety Issue:

No

Principal Investigator

Dr Craig Carr

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR3168

NCT ID:

NCT01032096

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

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