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Completed

NCT Number: NCT01032096

The Physiological Response to Routine Head and Neck Cancer Surgery

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM25PT, United Kingdom

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2009
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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