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The Physiological Response to Routine Head and Neck Cancer Surgery

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ClinicalTrials.gov Identifier: NCT01032096
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : May 23, 2016
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust

Brief Summary:
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

Condition or disease
Head and Neck Cancer

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.

Study Type : Observational
Estimated Enrollment : 15 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. The area under the curve for insulin concentration.
  2. Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
  3. Description of other blood parameters related to stress response.


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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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032096


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

Responsible Party: Dr Craig Carr, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01032096     History of Changes
Other Study ID Numbers: CCR3168
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms