The Physiological Response to Routine Head and Neck Cancer Surgery

NCT ID: NCT01032096

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Marsden NHS Foundation Trust

Principal Investigators

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Dr Craig Carr

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CCR3168

Identifier Type: -

Identifier Source: org_study_id

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