The Physiological Response to Routine Head and Neck Cancer Surgery

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

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM25PT
      • The Royal Marsden NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of cancer involving the head and neck region of the body.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Dr Craig Carr, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 20, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CCR3168