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The Physiological Response to Routine Head and Neck Cancer Surgery

This study has been completed.
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: December 14, 2009
Last updated: May 20, 2016
Last verified: May 2016
The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer

Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study

Resource links provided by NLM:

Further study details as provided by Royal Marsden NHS Foundation Trust:

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

Secondary Outcome Measures:
  • The area under the curve for insulin concentration.
  • Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
  • Description of other blood parameters related to stress response.

Estimated Enrollment: 15
Study Start Date: May 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of cancer involving the head and neck region of the body.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01032096

United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM25PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: Dr Craig Carr Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr Craig Carr, Royal Marsden NHS Foundation Trust Identifier: NCT01032096     History of Changes
Other Study ID Numbers: CCR3168
Study First Received: December 14, 2009
Last Updated: May 20, 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms processed this record on September 21, 2017