The Physiological Response to Routine Head and Neck Cancer Surgery

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT01032096
• Lead Sponsor: 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

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Description of other blood parameters related to stress response.
Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
The area under the curve for insulin concentration.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom