The Physiological Response to Routine Head and Neck Cancer Surgery

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032096
• Other study ID #: CCR3168
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: May 20, 2016
• Start date: May 2009
• Est. completion date: October 2012

Study information

• Verified date: May 2016
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.			No
Secondary	The area under the curve for insulin concentration.			No
Secondary	Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.			No
Secondary	Description of other blood parameters related to stress response.			No