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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01032096 |
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Date of registration:
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14/12/2009 |
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Primary sponsor: |
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Public title:
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The Physiological Response to Routine Head and Neck Cancer Surgery
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Scientific title:
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The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01032096 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Dr Craig Carr |
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Address:
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Telephone:
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02078118059 |
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Email:
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craig.carr@rmh.nhs.uk |
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Affiliation:
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Name:
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Dr Craig Carr |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Royal Marsden NHS Foundation Trust |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and Neck Cancer
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Primary Outcome(s)
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The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.
[Time Frame: No]
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Secondary Outcome(s)
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Description of other blood parameters related to stress response.
[Time Frame: No]
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Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
[Time Frame: No]
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The area under the curve for insulin concentration.
[Time Frame: No]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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