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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01032096

Enrollment

Registered

2009-12-15

Start date

2009-05-31

Completion date

2012-10-31

Last updated

2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results