The Physiological Response to Routine Head and Neck Cancer Surgery
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Status: Recruiting
Start Date
May 2009
Completion Date
October 2012
Sponsors
Royal Marsden NHS Foundation Trust
Source
Royal Marsden NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page